Description
keyboard_arrow_downMain Skills
keyboard_arrow_down GxP Pharmaceutical Industry
Other Skills
keyboard_arrow_down My SQL
database
SAP QM
SharePoint 2007
Ticketing System
SCRUM Methodology
business process management
Software Validation
Informatics
Oracle Fusion
Data validation
SPSS
MS-Office
Test Manager
MS Office 2010
DOCUMENTUM
SQL
Computer Science
SAP MM
MS Office 2007
IIS
agile software development methodology
Unix
Web Publishing
SDLC
databases
SAP
Windows
Clinical Trial Management System
Performance Monitoring
Requirements management
Siebel
Windows 7
Test Strategy
VPN
Public Key Infrastructure
Data Base
SAP srm
IT Infrastructure
ABAP
Citrix
SAS
Document Management
GxP
SCRUM
S-Plus
Agile
crossover
Linux
PIC
Minitab
Software Packaging
Agile Development
HP Service Manager
Opus
GPS
SAS data
Test Management
Release Management
Access
Reporting Tools
Clinical Data
SharePoint
Visio
CTMS
Oracle platform
Excel
PKI
Oracle
Modeling and Simulation
Work & Experience
keyboard_arrow_down 01.04.2016 — 31.07.2016
Novartis AG / Sandoz AG / Salutas Pharma GmbH Quality IT / e-Compliance
Project Manager Rampdown DEGE and Transfer to DEBA - OAKTree Projekt
Project Manager for the Rampdown plant DEGE (Salutas Pharma GmbH, Gerlingen-D) and Transfer to plant DEBA (Salutas Pharma GmbH, Barleben-D), Germany
e-Archiving and transfer project from all plant manufacturing (GMP) and laboratory(GMP, GLP) IT systems, according to controlling, HR and global interaction of Sandoz and Novartis
SELS Sandoz /Novartis, Novartis IGM Frame, Novartis ICE Method
Decommissioning of local environment from the Global System ( SAP, Sandoz GMP-Doc,etc.) 01.04.2016 — 31.07.2016
Boehringer-Ingelheim GmbH Methods Validation, Methods Evaluation, Methods Commercial Validation, Methods Verification, Methods Transfer, Reagent Classification in GMP-Laboratory Support
IDEA (Documentum) Training, Role: Doc-Coordinator, LOS Training (SOPs QA/QC/QS),
SAP CC (Change Control) GAP-Analysis 01.04.2016 — 31.07.2016
4
PM in QA/e-Compliance
Project Manager
Project Manager e-Archiving plant DEGE and Transfer to plant DEBA 01.01.2016 — Now
Sandoz QA / e-Compliance Training, 2016
GIS / IGM QM Trainings 2014, Novartis Basel Switzerland 2014
Development QA updated Trainings, LMS, Novartis Basel 2014
Computer System Regulations: EU Annex 11, 21 CFR Part 11 Novartis Basel, Switzerland 2013 01.12.2015 — 29.02.2016
Hewlett Packard - HP HealthCare International Pilot DRG project - Quality & Validation Engineer CSV Software Validation for DRG (Diagnosis Related Groups) Medical Costing Coding at University Hospital Zürich, SCRUM Methodology and Project Management, Agile Validation
Scrum Product Development Management as an iterative and incremental agile software development methodology, Zürich, Basel, Switzerland 01.01.2015 — Now
GMP - Auditor Lead Training Program (external & internal) TrackWise - DMS, Change, CAPA - modules - QA Manger Role
PAQ and CSV - Quality Management Program
Pharma Standort Technical - Quality Management Program
Utilities (Pharmaceutical Water & Gaze) -Quality Management Program
Optical Control Parenteral -Quality Management Program
QC (Quality Control) Microbiology - Deputy Quality Management Program
PK / PDKS / SPS -Quality Management Program
HP Service Manager - Quality Manager
ELVIS - Engineering QA Manager Role
SAP QM - Quality Manager
SAP MM, PM, FI, CO -Program
PK / PDKS / SPS -Quality Management Program
Liquids and Lyophilisation - Deputy Quality Management Program
QE - Quality Assurance Engineering for Kaiseraugst
ConDor Training - Quality Manager Role
PT Risk Manger Training - Quality Manger Role
CTMS (Clinical Trial Management System) -Business Program
PTQBFB_001: Bundesgesetz über Arzneimittel und Medizinprodukte (HMG, Schweiz)
PTQBFB_002: Verordnung über die Bewilligung im Arzneimittelbereich (AMBV, Schweiz)
PTQBFB_003: EU GMP-GUIDE
PTQBFB_004: FDA Current GMP in Manufacturing, Processing, Packing or Holding of Drugs, 21 CFR part 210
PTQBFB_005: FDA Current GMP for Finished Pharmaceuticals, 21 CFR Part 211
PTQBFB_006: FDA Guidance for Industry: Q9 Quality Risk Management
PTQBFB_007: FDA 21 CFR Part 11 Final Rule
PTQBFB_008: FDA Guidance for Industry Part 11, ER, ES -Scope and Application
PTQBFB_009: FDA General Principles of Software Validation; Final Guidance Industry& FDA Staff
PTQBFB_010: FDA / ORA CPG 7132a.11 Compliance Policy Guide 425.100 Computerized Drug, CGMP Applicability to Hardware and Software
PTQBFB_011: FDA / ORA CPG 7132a.15 Compliance Policy Guide 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs
PTQBFB_014: PIC /S Guide to GMP of Medicinal Products
PTQBFB_015: PIC /S Guidance Good Practices for Computerized Systems in regulated "GxP" Environments
PTQBFB_016: EU Guidel., GMP Medicinal Products, Human &Veterinary Use EudraLex Vol 4-Part 1
PTQBFB_017: EU Guidel.. GMP Medicinal Products, Human &Veterinary Use EudraLex Vol 4-Part 2
PTQBFB_018: EU Guidelines to GMP Medicinal Products for Human and Veterinary Use EudraLex Volume 4 - Annex 11
PTQBFB_019: EU Guidelines to GMP Medical Products for Human and Veterinary Use EudraLex Volumen 4 - Annex 15
PTQBFB_020: Pharma Manufacturing Standards
PTQBFB_023: FDA Guidance Aseptic Processing
PTQBFB_024: EU Guidelines to GMP, Manufacture of Sterile Medicinal Products - Annex 1
Training to MHRA - Data Integrity Guide 01.09.2014 — 31.12.2014
4
QM Roll-out Project ,
Novartis
QM Manager
Roll-out Application Migration GIS / IGM 01.07.2014 — 31.12.2015
Quality Engineering -Quality Assurance Manager Parenteral Manufacturing and PST (Pharma Standort Technik Basel)
Quality Assurance Manager for cGMP - Production (operational & projects)
Design, Controlling and Verification of product technical activities
GEMBA - Walks ( management by walking around through manufacturing site
Optical Control, Production Control System, Process Data Communication
Deputy QA Manager for Liquids, Lyophilisation, Solution, Service, MSAT
Trackwise - Deviation, Investigation, Change, CAPA QA Manager
Trackwise - Project Interface to PK -System
PK-System (Produktionskontroll-System), QA Manager
PDKS - System(Prozessdatenkommunikationsservern) QA Manager
SPS System (Speicherprogrammierbaren Steuerungen) QA Manager
Automation Project - S5 to S7 upgrade - QA Manager
Quality Risk Manager - QRM - PT Risk Managment
CSV - Quality Management Roche Community Basel
CSV Auditor for more than 150 softwares
Internal and External GxP Auditor 01.07.2014 — 31.12.2015
QA Manager Parenteral Manufacturing and PST 01.01.2014 — 31.12.2015
Congresses
Member of CSV Community Roche Basel, Switzerland, 2014 - 2015
Member of Global Pharma IGM Group Novartis - Basel, Switzerland, since 2012 01.06.2013 — 31.12.2013
Quality Manager and IGM Manager for the Global Roll-out Application Migration to HCL ones from Novartis, Sandoz and Alcon stored on IBM hosted servers. Basel, Switzerland 01.06.2013 — 31.12.2013
Quality and Standards Systems - QSS Training Core Team
Global Roll-out to Quality and Standards Systems on the Job Roles related Training Process reflected on different platforms, STAR, LMS, ESOPs, DevQMS. Basel, Switzerland 01.06.2013 — 31.12.2013
(DePuy Synthes, Zuchwil, Waldenburg, Oberdorf)
GRQP (Global Remediation Quality Plan) Pilot Phase - Quality & Validation Engineer
CSV Software / Equipment Validation, SDLC Methodology
Risk Management
GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11 etc.
SDLC/Validation/Testing/Migration for the MDM system in line with the above objectives and as agreed with the SO, CSQA and Global IT Validation CoE, Basel, Switzerland 01.06.2013 — 31.12.2013
7
Dev QA - QSS
Training Roll-out, Novartis
Business
Analyst
Roll-out, Validation, Training, Operational support for Global Pharma Development 01.01.2013 — 31.12.2016
Medical Devices & HealthCare 01.01.2013 — Now
LMS Administrator Training 01.08.2012 — 31.03.2013
AQWA QE - Core Team - Business Analyst AQWA QE-Quality Event (&Deviation, Incidents, Actions) modules - Core Team Member in Roll-out within TrackWise system the AQWA (Adaptable Quality Workflow Application) - in Validation, Go-live and
Training EU/Africa, Americas/Canada and Asia Pacific regions for Pharma Development. (Key Users and Users > 400 System Members, Process covered by > 10'000 Business Members). Building of Business Competence Centre cross over divisions, Basel Switzerland 01.08.2012 — 31.03.2013
Global roll-out AQWA QE for Pharma Development, Novartis Roll-out, Validation, Training, Operational support for Global Pharma Development 01.05.2012 — 31.07.2012
Change Control of Excellence (CCEx) Quality Management Leader for the Acceleration Phase. Designing Project Lifecycle Management for Production on Oracle platform,
Agile Validation, Basel Switzerland 01.04.2012 — 31.12.2012
Report from Dragon and AQWA link - done by RegCMC (Regulatory Chemistry, Manufacturing and Controls) for Business Crossover Processes between DRA (Drug Regulatory Affairs) and PhSc (Pharma Supply Chain), Basel Switzerland 01.04.2012 — 31.12.2012
9
DRA Quest report RegCMC crossover departments DRA to Supply Chain, Novartis
Business Analyst
Running and Analyzing the DRA Quest report for RegCMC from data sourcing to KPI 01.01.2012 — Now
Member of Pharma Development QA / IGM Group 01.01.2012 — Now
Enterprise Architecture Training, Novartis Basel Switzerland, 2012 01.11.2011 — 31.05.2012
Artwork Next Generation (ANG) Quality Management Leader. Designing Project Lifecycle Management for Production on Oracle platform
Agile Validation, Basel Switzerland 01.11.2011 — 30.06.2012
14
Qualification of a global IT Infrastructure, Novartis, TechOps
Project Quality Manager
New server landscape qualification and new service implementation, as well as Software, Configuration and Data Base move. 01.10.2011 — 31.01.2012
PQR-APR Project - Test Manager Lead im Quality Management Team Lead Testing crossover platforms of SAP, AQWA, Minitab, Oracle Fusion. Project LifecycleManagement in Production, Basel, Switzerland 01.10.2011 — 31.01.2012
Hoffmann La Roche - pRED Informatics Business Analyst implementation of Mosaic / Quality
Mosaic Roll-out Global, Quality Process
Process Flow implementation in Early Development IT, Basel, Switzerland 01.10.2011 — 31.01.2012
Business Analyst/ Quality 4
Global roll-out in Roche, pRED
Business Analyst/
Quality
Roll-out Mosaic product for business process management. Set-up a Global Rollout Strategy, as well as Quality and Process Manual. Consult and support Local and Rollout Team in Quality and Process Issues. 01.02.2011 — 31.05.2011
TRD - (Technical Research & Development)
LeadLab03 Project - Business Analyst and Quality Management in CSV for Lab.
Pilot Project, Computer System Validation CSV for Lab (ie. Opus, Winsotax, UVWinLab, Calibry, Tiamo, DiffracPlus, eStar, SoftMaxPro etc) related to IT Auditing requests, ITIL Management for CHAD, PHAD and PSP /CS- QC; SOP, ERES, URS, IQ/OQ/PQ, I-Man Ticketing System, DiARy on My SQL and Oracle rational databases, Basel Switzerland 01.02.2011 — 31.05.2012
Business Analyst/ Quality LeadLab03 Project, Validation and Quality Assurance for Audit 01.01.2011 — Now
ICE Bronze (Project Management) Training, 2008, 2010 01.05.2010 — 30.04.2011
University Hospital Basel SharePoint 2007 Process Flows implementation for Clinical Trials. Basel Switzerland 01.01.2008 — 30.06.2010
Novartis Pharma AG - Development IT - Analytical Systems Project Manager / Quality Manager / Solution Architect / Business Analyst Integrated Information Science and Informatics - CD&MA (Clinical Data and Medical Affairs) - Clinical & Safety DSG - Analytical Systems
Process modeling and Requirements management; IT Controlling, maintaining SLA (Service Level Agreements), OLA (Operation Level Agreements), OLM (Operation Level Management) to 3part vendors in legal terms and conditions, Procedures Quality Performance Monitoring Statistical Tools installation support, Testing for different platforms (Windows, Unix, Linux, Citrix) on Novartis IT architecture and Management Specialist for the SAS Competence Centre;
Software Packaging and License Management related to project schedules and budgeting at Business Intelligence Competence Centre, Compliant Agile Development, Standard Operating Procedures (SOP's); on My SQL and Oracle rational databases
Archiving Documentation via ESOP, DiARy, xREDI systems
Helpdesk Ticketing System (I-MAN) 2nd level Support for SAS and Statistical Tools; Configuration/Change/Release Management and Processes maintenance related to the
Service Portfolio and Solution Catalog; Reporting Tools; CREDI, DiAry, ESOP, Clarity Tool, GCM, ACG, B&SR databases, SharePoint Pilot Project, MS Office 2007 Pilot Project, Windows 7 Pilot Project ; KPI performance appraisals
MS Office 2010 Pilot Project for Analytical Systems Department SAS and Statistical Tools
Due Diligence (DD), KPI assessments for Outsourcing Management, Outsourcing Training, Reverse Check according to internal and external resourcing, Validation specified requests and processes in frame to budget and time factors
ICE Methodology, PM Methodology, ITIL management; CSV (Computer System Validation) according FDA requirements;
SOX, GxP Audits, Project Quality Management GxP to Risk and Compliance Process Flows; Technical Tester, ESOPS, Testing for IIS (Integrated Information Science - previous CIS department) Oncology and M&S (Modeling and Simulation);
Installation&Validation of containers i.e.S-Plus 8.1.1, SAS 9.2-2, SAS EnterpriseGuide, StatXact8,Matlab2009a,Addplan5MC_5.02,East 5.3,R 2.8.1, RTools 2.8, MS Office 2007 etc.
Following data models and interchange standards (CDISC, SDTM, ADaM);
PKI (Public Key Infrastructure) user certification VPN access and e-signature. Training in CA, RA, VA (Certificate, Registration and Validation Authority)
CPS (Certificate Practice Statement) and Certificate Policy
Consulting for other departments using SAS installation for Marketing, TechOps, Vaccines & Diagnostic etc.
User and Vob Data-migration related to the clinical trials for new structured Therapeutically Area on Unix GPS II Novartis;
Adverse Event Reporting & Drug Safety Compliance Training, Basel, Switzerland 01.01.2008 — 31.12.2016
Attendance LifeScience Forum 01.01.2008 — 31.03.2010
SAS and Statistical Tools - Competence Center, Novartis Project Manager/Quality Manager/ Solution Architect /Business Analyst Validation of all statistical tools. Competence Center Responsible. New Projects implementation. Responsible for deviation reporting, deviation impact assessment, corrective and preventive action analysis, as well as deviation investigation reporting 01.10.2007 — 31.08.2008
University Hospital Basel Roll-Out Ward Logistic with SRM - (SAP/SRM, Supplier Relationship Management),
Optimization of Drugs and Goods Logistic cross-over Hospital Wards
Process Flow Management in ARIS, Basel, Switzerland 01.04.2007 — 31.12.2007
Business Analyst implementation of CTMS Pharma Development Operations, Clinical Trial Management System (CTMS) as CTMS Support Group Specialist for different IT tools. Validation of Data-migration into CTMS.
Interfaces from My SQL and Oracle rational databases and Archiving Documentation
Adverse Event Reporting & Drug Safety Compliance Training - Basel, Switzerland 01.03.2007 — 31.12.2007
Business Analyst/ Quality Validation of CTMS e-Siebel product for business process management. 01.04.2006 — 30.04.2007
University Hospital Basel - Radiology Department Study Management for Multicentre Study with different CRO's, investigators, 3part vendors, physicians Neuroradiology MS-MRI Evaluation Centre Basel, Evaluation marking and segmentation of MRI imagines for several studies according to their medication, measuring of volumes and flair difference during the follow up treatment, Basel, Switzerland 01.01.2005 — 31.12.2016
MipTec Congress - BioValley & Life Science 01.01.2005 — 31.12.2016
University Hospital Basel Attendance MedArt Congress Research, Medical and Pharmaceutical Seminars University Hospital Basel, Switzerland, since 2002 01.02.2004 — 28.02.2006
University Hospital Basel - Infections Control Department Infection control and hospital Epidemiology department / Study Management for Multicentre Study with different CRO's, investigators, 3part vendors, physicians
Clinical Study Data Management -
Central Venous Catheter associated nosocomial infection study by surgical patients. Monitoring of patient during the surgery to the ICU/CCU room and on the surgery ward, Microbiologic Lab Analysis, SPSS medical statistics, Data validation, Quality management MRSA study, Implant - surgical biofilm study, SIRS study - Management of Bloodstream infection and administration of antibiotic pre-surgical and during surgery, SPSS medical statistics, Lab Data validation and Quality management HIP and Knee Study - Orthopaedic department , SPSS medical statistics Data validation and Quality management, Basel, Switzerland 01.10.2002 — 31.05.2005
University Hospital Basel - Traumatology Department Study coordination Polytrauma casualty - Clinical Study Data Management - conventional treatment in EMR reanimation room compared with once in a prototype operating room MBI.
Developing CRF and Patients questioning, statistic in Excel, Access, SPSS part of medical, socio-economics evaluation, at the Surgical Department, University Hospital of Basel, Basel, Switzerland 01.01.2002 — 30.06.2002
Hoffmann La Roche - Vitamins Europe Finance as a Business Administration Assistant for SAP Intra-Stat and VAT. secondary working in the Controlling Team and IT Support, Birsfelden, Switzerland 01.06.2001 — 31.12.2001
Hoffmann La Roche - Vitamins Europe iQL (IT enabled Quantum Leap) Program Management Team, Status Reporting, IQL Cost Controlling, Web presence. Monitoring the SAP Q26 documentation at central level
Working for the Business Warehouse (BW) Upgrade 2x project, Export_Market project, B2Q project, e-Commerce_pilot project and e-Commerce_Customer_Initiative_Phase II project, RVE_Small_Medium_Sites project at Roche Vitamins AG, VSEP- Roche Vitamins IT Service Europe Projects, Kaiseraugst, Switzerland 01.01.2001 — 30.06.2001
Hoffmann La Roche - Vitamins Europe; VSEP iQL (IT enabled Quantum Leap) Program Management Team; Monitoring the SAP Q26 documentation at central level
Working on the RVE_iQL Sales Reorganization Project, SRO Training project, GMMIII_Application project and RVE_e-Commerce_Sales, at F. Hoffmann-La Roche AG (Vitamins and Fine Chemicals), RVE-Roche Vitamins Europe
VSEP- Roche Vitamins IT Service Europe Project, Birsfelden, Switzerland 01.06.2000 — 31.12.2000
Hoffmann La Roche - Vitamins Europe Q26 SAP Upgrade and Optimise Project; The Q26 specifically SAP-programs documented from ABAP. Project documentation according to PMG (Program Management Guidelines);
Status User Manuals; Business Process Flows-Changes (Visio); Web Publishing of Business Process Flows; Time Sheets,
Costs Reporting, Invoice Checks; at F. Hoffmann-La Roche AG (Vitamins and Fine Chemicals), VSEP- Roche Vitamins IT Service Europe Projects, Birsfelden, Switzerland 01.06.2000 — 30.06.2002
Business Analyst/ Quality Roll-out of different SAP projects 01.07.1999 — 31.03.2000
Novartis Pharma AG - Development IT - Analytical Systems IT/Pharma Business Analyst, Quality, Tester SAS data migration from MVS to UNIX , at the Pharma Novartis Company, (Computer Science Corporation - CSC Ploenzke)
Working for Testing, Migration, Documentation, Updating from database -coordinated with Pharma Novartis USA in VMS. Basel, Switzerland 01.07.1999 — 30.04.2000
Business Analyst/ Quality / Tester Sandoz - Pharma
Novartis - Pharma
Business Analyst/
Quality / Tester
SAS Migration from MVS to Unix
Core responsibilities & achievements
Innovatively leading and managing projects in multiple locations.
Trouble shooting key bottlenecks in Quality Management & Delivery process globally.
Determine new methods & develops new procedures based on the requirements of a situation
Designing a new Test Management Procedure for documentation that brings improvement of the system to meet compliance with Novartis and Roche, SOX & GxP (e.g. FDA, EMEA, GAMP5) regulatory requirements.
Managing the results of quality & testing teams to ensure compliance with ICE methodology.
Accountable for project deliverables (Validation/Quality/Project Plan, Test Strategy & Test Plan)
Conducting quality reviews to evaluate if process & deliverables fulfill the requirements for quality assurance & testing.
Managing Business Process Analysis & Modeling - Business Guidance Author.
Project communication to key stakeholders and ensuring that project quality targets were met in budget and time constraints.
Conducting steering committee and team meetings, trainings (Testers training) & assessments (Functional or Project Risk Assessment, Business Impact Assessment).
Documentation Management - writing & approving validation documents, preparation of project-related documents for final approval, publishing documents in SharePoint.
Configuration & Change Management - Establish & maintain consistency of the system to track & control changes.
Johnson & Johnson
GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
Boehringer-Ingelheim
IDEA Training - DocCoordinator Rolle, Biberach Germany 2016
LOS Training (SOPs QA/QC/QS)
SAP CC (Change Control)
Novartis Training Extract 01.01.1999 — Now
PHARMACEUTICAL INDUSTRY ( Novartis, Roche, Sandoz, Salutas Pharma, Boehringer-Ingelheim); Global Pharma Projects; Novartis AG Quality Manager/Auditor and Business Analyst Consultant In this rols I have been hired to deliver on several critical projects within Pharmaceutical Industry.
Pharmaceutical, Novartis AG, Sandoz AG - Germany
Salutas Pharma GmbH 01.01.1999 — 31.12.2008
DocNav (Document Management Platform) Training, 2011
ESOPS (Document Management Platform) Training, 2009
Diary (Document Management Platform) Training, 2008, 2010, 2011 01.01.1999 — 31.12.2000
Novartis Dev IT, EWS WebSDG, TechOps SOP & WP Trainings More detailed information available on request. 01.08.1997 — Now
MedLab Conferance - Member of the Conference organization staff, provided statistical consulting in scientific presentation: Variation on positives and negatives results in Medical Laboratorium, Basel, Switzerland 01.01.1997 — 30.04.2001
SBK - Schweizerischen Berufsverband für Krankenschwestern/Pflegern Medical Attendance of Patients as Member of the Swiss Professional Union of Nurses (SBK-Schweizerischen Berufsverband für Krankenschwestern/pflegern), (since 1998 - weekend - stand by duty), Switzerland 01.03.1996 — Now
University Hospital Basel - Psychiatric Department; Psychiatric University Outpatient's Clinic 01.08.1995 — 30.09.1995
Practical training in the medical-diagnostic Laboratories of the Dr. Viollier Institute, Allschwil, Switzerland 01.07.1995 — Now
University Hospital Basel - Geriatric Department; Geriatric Department (ward-institutional care), Basel University Hospital (KBS) 01.01.1994 — 31.12.1996
ClinPharm Birsfelden - Clinical Department ClinPharm Birsfelden, blood-taking, Laboratory, Monitoring ECG, Statistical Analysis, medical attendance of probands in clinical drug trials, Swizterland 01.01.1993 — 31.12.1996
Ita Wegman - Clinic - Ward Care Ita Wegman-Clinic (ward-institutional care), (Internal Medicine, Obstretic- and Children's Departments), specialised education, Arlesheim Switzerland 01.11.1991 — 30.06.1999
University Hospital Basel - Chronobiology Department Study Management
Chronobiology Department in the Psychiatric University Clinic Basel (PUK-Psychiatrische Universitäts Klinik) - Clinical Study Data Management - Monitoring ECG, EEG, EMG, EOG, Laboratory, statistical Analysis for clinical drug trials, medical attendance of probands, Basel, Switzerland 01.11.1991 — 30.06.1999
Referent Transaction Process Flows 01.01.1991 — 31.12.2012
HealthCare Institutions; Zürich Hospital Triemli Day Care Emergency Unit Building - Implementation
Process Optimization for the new inaugurated Day Care Emergency Unit Building - commitment in urgently required process stream
Windows 7 Roll-out with system interfaces from My SQL and Oracle rational databases - Documentum Archiving, Zürich, Switzerland 01.03.1989 — 31.12.1989
Air-Conditioning & Heating Systems Institute of Air-Conditioning and Heating Systems, Technical Design and Technical Translation (G-E-It-Sp/Ro) for the building of the technical database.
(Working Student) 01.06.1988 — 30.06.1991
Tourist Guide and Translation from English and German to Romanian 01.06.1986 — 30.09.1986
Technical Translations (G/Ro) of Handbooks in Ozone therapy, Assistant in the Outpatient's Clinic No. 2 in the Ozone Therapy Department, Sector 2 Bucharest. PHARMACEUTICAL INDUSTRY ( Novartis, Roche, Sandoz, Salutas Pharma, Boehringer-Ingelheim); Global Pharma Projects; Novartis AG Quality Manager/Auditor and Business Analyst Consultant In this rols I have been hired to deliver on several critical projects within Pharmaceutical Industry.
Pharmaceutical, Novartis AG, Sandoz AG - Germany
Salutas Pharma GmbH Novartis AG / Sandoz AG / Salutas Pharma GmbH Quality IT / e-Compliance
Project Manager Rampdown DEGE and Transfer to DEBA - OAKTree Projekt
Project Manager for the Rampdown plant DEGE (Salutas Pharma GmbH, Gerlingen-D) and Transfer to plant DEBA (Salutas Pharma GmbH, Barleben-D), Germany
e-Archiving and transfer project from all plant manufacturing (GMP) and laboratory(GMP, GLP) IT systems, according to controlling, HR and global interaction of Sandoz and Novartis
SELS Sandoz /Novartis, Novartis IGM Frame, Novartis ICE Method
Decommissioning of local environment from the Global System ( SAP, Sandoz GMP-Doc,etc.) Pharmaceutical, Novartis AG Pharmaceutical, Novartis AG, Basel Switzerland
(more than 10 years work experience ) Quality Manager and IGM Manager for the Global Roll-out Application Migration to HCL ones from Novartis, Sandoz and Alcon stored on IBM hosted servers. Basel, Switzerland Quality and Standards Systems - QSS Training Core Team
Global Roll-out to Quality and Standards Systems on the Job Roles related Training Process reflected on different platforms, STAR, LMS, ESOPs, DevQMS. Basel, Switzerland AQWA QE - Core Team - Business Analyst AQWA QE-Quality Event (&Deviation, Incidents, Actions) modules - Core Team Member in Roll-out within TrackWise system the AQWA (Adaptable Quality Workflow Application) - in Validation, Go-live and
Training EU/Africa, Americas/Canada and Asia Pacific regions for Pharma Development. (Key Users and Users > 400 System Members, Process covered by > 10'000 Business Members). Building of Business Competence Centre cross over divisions, Basel Switzerland Report from Dragon and AQWA link - done by RegCMC (Regulatory Chemistry, Manufacturing and Controls) for Business Crossover Processes between DRA (Drug Regulatory Affairs) and PhSc (Pharma Supply Chain), Basel Switzerland Change Control of Excellence (CCEx) Quality Management Leader for the Acceleration Phase. Designing Project Lifecycle Management for Production on Oracle platform,
Agile Validation, Basel Switzerland Artwork Next Generation (ANG) Quality Management Leader. Designing Project Lifecycle Management for Production on Oracle platform
Agile Validation, Basel Switzerland PQR-APR Project - Test Manager Lead im Quality Management Team Lead Testing crossover platforms of SAP, AQWA, Minitab, Oracle Fusion. Project LifecycleManagement in Production, Basel, Switzerland TRD - (Technical Research & Development)
LeadLab03 Project - Business Analyst and Quality Management in CSV for Lab.
Pilot Project, Computer System Validation CSV for Lab (ie. Opus, Winsotax, UVWinLab, Calibry, Tiamo, DiffracPlus, eStar, SoftMaxPro etc) related to IT Auditing requests, ITIL Management for CHAD, PHAD and PSP /CS- QC; SOP, ERES, URS, IQ/OQ/PQ, I-Man Ticketing System, DiARy on My SQL and Oracle rational databases, Basel Switzerland Novartis Pharma AG - Development IT - Analytical Systems Project Manager / Quality Manager / Solution Architect / Business Analyst Integrated Information Science and Informatics - CD&MA (Clinical Data and Medical Affairs) - Clinical & Safety DSG - Analytical Systems
Process modeling and Requirements management; IT Controlling, maintaining SLA (Service Level Agreements), OLA (Operation Level Agreements), OLM (Operation Level Management) to 3part vendors in legal terms and conditions, Procedures Quality Performance Monitoring Statistical Tools installation support, Testing for different platforms (Windows, Unix, Linux, Citrix) on Novartis IT architecture and Management Specialist for the SAS Competence Centre;
Software Packaging and License Management related to project schedules and budgeting at Business Intelligence Competence Centre, Compliant Agile Development, Standard Operating Procedures (SOP's); on My SQL and Oracle rational databases
Archiving Documentation via ESOP, DiARy, xREDI systems
Helpdesk Ticketing System (I-MAN) 2nd level Support for SAS and Statistical Tools; Configuration/Change/Release Management and Processes maintenance related to the
Service Portfolio and Solution Catalog; Reporting Tools; CREDI, DiAry, ESOP, Clarity Tool, GCM, ACG, B&SR databases, SharePoint Pilot Project, MS Office 2007 Pilot Project, Windows 7 Pilot Project ; KPI performance appraisals
MS Office 2010 Pilot Project for Analytical Systems Department SAS and Statistical Tools
Due Diligence (DD), KPI assessments for Outsourcing Management, Outsourcing Training, Reverse Check according to internal and external resourcing, Validation specified requests and processes in frame to budget and time factors
ICE Methodology, PM Methodology, ITIL management; CSV (Computer System Validation) according FDA requirements;
SOX, GxP Audits, Project Quality Management GxP to Risk and Compliance Process Flows; Technical Tester, ESOPS, Testing for IIS (Integrated Information Science - previous CIS department) Oncology and M&S (Modeling and Simulation);
Installation&Validation of containers i.e.S-Plus 8.1.1, SAS 9.2-2, SAS EnterpriseGuide, StatXact8,Matlab2009a,Addplan5MC_5.02,East 5.3,R 2.8.1, RTools 2.8, MS Office 2007 etc.
Following data models and interchange standards (CDISC, SDTM, ADaM);
PKI (Public Key Infrastructure) user certification VPN access and e-signature. Training in CA, RA, VA (Certificate, Registration and Validation Authority)
CPS (Certificate Practice Statement) and Certificate Policy
Consulting for other departments using SAS installation for Marketing, TechOps, Vaccines & Diagnostic etc.
User and Vob Data-migration related to the clinical trials for new structured Therapeutically Area on Unix GPS II Novartis;
Adverse Event Reporting & Drug Safety Compliance Training, Basel, Switzerland Novartis Pharma AG - Development IT - Analytical Systems IT/Pharma Business Analyst, Quality, Tester SAS data migration from MVS to UNIX , at the Pharma Novartis Company, (Computer Science Corporation - CSC Ploenzke)
Working for Testing, Migration, Documentation, Updating from database -coordinated with Pharma Novartis USA in VMS. Basel, Switzerland Pharmaceutical, Hoffman-La Roche AG Pharmaceutical, Hoffman-La Roche AG, Basel Switzerland
(more than 7 years work experience) Quality Engineering -Quality Assurance Manager Parenteral Manufacturing and PST (Pharma Standort Technik Basel)
Quality Assurance Manager for cGMP - Production (operational & projects)
Design, Controlling and Verification of product technical activities
GEMBA - Walks ( management by walking around through manufacturing site
Optical Control, Production Control System, Process Data Communication
Deputy QA Manager for Liquids, Lyophilisation, Solution, Service, MSAT
Trackwise - Deviation, Investigation, Change, CAPA QA Manager
Trackwise - Project Interface to PK -System
PK-System (Produktionskontroll-System), QA Manager
PDKS - System(Prozessdatenkommunikationsservern) QA Manager
SPS System (Speicherprogrammierbaren Steuerungen) QA Manager
Automation Project - S5 to S7 upgrade - QA Manager
Quality Risk Manager - QRM - PT Risk Managment
CSV - Quality Management Roche Community Basel
CSV Auditor for more than 150 softwares
Internal and External GxP Auditor HP Service Manager - Quality Manager Lean & Six Sigma Methodologies used in different projects cross over departments
SOP-Standard Operation Procedure Quality Review and Approval
Process Flow Compliance in Biological Product Manufacturing
QA Manager for Utilities Basel (Pharmaceutical Mediums, Gaz, Water, Energie) PST 'Pharma Standort Technik' Quality Assurance Manager Hoffmann La Roche - pRED Informatics Business Analyst implementation of Mosaic / Quality
Mosaic Roll-out Global, Quality Process
Process Flow implementation in Early Development IT, Basel, Switzerland Business Analyst implementation of CTMS Pharma Development Operations, Clinical Trial Management System (CTMS) as CTMS Support Group Specialist for different IT tools. Validation of Data-migration into CTMS.
Interfaces from My SQL and Oracle rational databases and Archiving Documentation
Adverse Event Reporting & Drug Safety Compliance Training - Basel, Switzerland Hoffmann La Roche - Vitamins Europe Finance as a Business Administration Assistant for SAP Intra-Stat and VAT. secondary working in the Controlling Team and IT Support, Birsfelden, Switzerland Hoffmann La Roche - Vitamins Europe iQL (IT enabled Quantum Leap) Program Management Team, Status Reporting, IQL Cost Controlling, Web presence. Monitoring the SAP Q26 documentation at central level
Working for the Business Warehouse (BW) Upgrade 2x project, Export_Market project, B2Q project, e-Commerce_pilot project and e-Commerce_Customer_Initiative_Phase II project, RVE_Small_Medium_Sites project at Roche Vitamins AG, VSEP- Roche Vitamins IT Service Europe Projects, Kaiseraugst, Switzerland Hoffmann La Roche - Vitamins Europe; VSEP iQL (IT enabled Quantum Leap) Program Management Team; Monitoring the SAP Q26 documentation at central level
Working on the RVE_iQL Sales Reorganization Project, SRO Training project, GMMIII_Application project and RVE_e-Commerce_Sales, at F. Hoffmann-La Roche AG (Vitamins and Fine Chemicals), RVE-Roche Vitamins Europe
VSEP- Roche Vitamins IT Service Europe Project, Birsfelden, Switzerland Hoffmann La Roche - Vitamins Europe Q26 SAP Upgrade and Optimise Project; The Q26 specifically SAP-programs documented from ABAP. Project documentation according to PMG (Program Management Guidelines);
Status User Manuals; Business Process Flows-Changes (Visio); Web Publishing of Business Process Flows; Time Sheets,
Costs Reporting, Invoice Checks; at F. Hoffmann-La Roche AG (Vitamins and Fine Chemicals), VSEP- Roche Vitamins IT Service Europe Projects, Birsfelden, Switzerland Boehringer-Ingelheim GmbH Methods Validation, Methods Evaluation, Methods Commercial Validation, Methods Verification, Methods Transfer, Reagent Classification in GMP-Laboratory Support
IDEA (Documentum) Training, Role: Doc-Coordinator, LOS Training (SOPs QA/QC/QS),
SAP CC (Change Control) GAP-Analysis Medical Devices & HealthCare Hewlett Packard - HP HealthCare International Pilot DRG project - Quality & Validation Engineer CSV Software Validation for DRG (Diagnosis Related Groups) Medical Costing Coding at University Hospital Zürich, SCRUM Methodology and Project Management, Agile Validation
Scrum Product Development Management as an iterative and incremental agile software development methodology, Zürich, Basel, Switzerland (DePuy Synthes, Zuchwil, Waldenburg, Oberdorf)
GRQP (Global Remediation Quality Plan) Pilot Phase - Quality & Validation Engineer
CSV Software / Equipment Validation, SDLC Methodology
Risk Management
GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11 etc.
SDLC/Validation/Testing/Migration for the MDM system in line with the above objectives and as agreed with the SO, CSQA and Global IT Validation CoE, Basel, Switzerland HealthCare Institutions; Zürich Hospital Triemli Day Care Emergency Unit Building - Implementation
Process Optimization for the new inaugurated Day Care Emergency Unit Building - commitment in urgently required process stream
Windows 7 Roll-out with system interfaces from My SQL and Oracle rational databases - Documentum Archiving, Zürich, Switzerland University Hospital Basel SharePoint 2007 Process Flows implementation for Clinical Trials. Basel Switzerland University Hospital Basel Roll-Out Ward Logistic with SRM - (SAP/SRM, Supplier Relationship Management),
Optimization of Drugs and Goods Logistic cross-over Hospital Wards
Process Flow Management in ARIS, Basel, Switzerland University Hospital Basel - Radiology Department Study Management for Multicentre Study with different CRO's, investigators, 3part vendors, physicians Neuroradiology MS-MRI Evaluation Centre Basel, Evaluation marking and segmentation of MRI imagines for several studies according to their medication, measuring of volumes and flair difference during the follow up treatment, Basel, Switzerland University Hospital Basel - Infections Control Department Infection control and hospital Epidemiology department / Study Management for Multicentre Study with different CRO's, investigators, 3part vendors, physicians
Clinical Study Data Management -
Central Venous Catheter associated nosocomial infection study by surgical patients. Monitoring of patient during the surgery to the ICU/CCU room and on the surgery ward, Microbiologic Lab Analysis, SPSS medical statistics, Data validation, Quality management MRSA study, Implant - surgical biofilm study, SIRS study - Management of Bloodstream infection and administration of antibiotic pre-surgical and during surgery, SPSS medical statistics, Lab Data validation and Quality management HIP and Knee Study - Orthopaedic department , SPSS medical statistics Data validation and Quality management, Basel, Switzerland University Hospital Basel - Traumatology Department Study coordination Polytrauma casualty - Clinical Study Data Management - conventional treatment in EMR reanimation room compared with once in a prototype operating room MBI.
Developing CRF and Patients questioning, statistic in Excel, Access, SPSS part of medical, socio-economics evaluation, at the Surgical Department, University Hospital of Basel, Basel, Switzerland University Hospital Basel - Chronobiology Department Study Management
Chronobiology Department in the Psychiatric University Clinic Basel (PUK-Psychiatrische Universitäts Klinik) - Clinical Study Data Management - Monitoring ECG, EEG, EMG, EOG, Laboratory, statistical Analysis for clinical drug trials, medical attendance of probands, Basel, Switzerland MedLab Conferance - Member of the Conference organization staff, provided statistical consulting in scientific presentation: Variation on positives and negatives results in Medical Laboratorium, Basel, Switzerland Referent Transaction Process Flows SBK - Schweizerischen Berufsverband für Krankenschwestern/Pflegern Medical Attendance of Patients as Member of the Swiss Professional Union of Nurses (SBK-Schweizerischen Berufsverband für Krankenschwestern/pflegern), (since 1998 - weekend - stand by duty), Switzerland University Hospital Basel - Psychiatric Department; Psychiatric University Outpatient's Clinic Practical training in the medical-diagnostic Laboratories of the Dr. Viollier Institute, Allschwil, Switzerland University Hospital Basel - Geriatric Department; Geriatric Department (ward-institutional care), Basel University Hospital (KBS) ClinPharm Birsfelden - Clinical Department ClinPharm Birsfelden, blood-taking, Laboratory, Monitoring ECG, Statistical Analysis, medical attendance of probands in clinical drug trials, Swizterland Ita Wegman - Clinic - Ward Care Ita Wegman-Clinic (ward-institutional care), (Internal Medicine, Obstretic- and Children's Departments), specialised education, Arlesheim Switzerland Congresses
Member of CSV Community Roche Basel, Switzerland, 2014 - 2015
Member of Global Pharma IGM Group Novartis - Basel, Switzerland, since 2012 Member of Pharma Development QA / IGM Group Attendance LifeScience Forum MipTec Congress - BioValley & Life Science University Hospital Basel Attendance MedArt Congress Research, Medical and Pharmaceutical Seminars University Hospital Basel, Switzerland, since 2002 Air-Conditioning & Heating Systems Institute of Air-Conditioning and Heating Systems, Technical Design and Technical Translation (G-E-It-Sp/Ro) for the building of the technical database.
(Working Student) Tourist Guide and Translation from English and German to Romanian Technical Translations (G/Ro) of Handbooks in Ozone therapy, Assistant in the Outpatient's Clinic No. 2 in the Ozone Therapy Department, Sector 2 Bucharest. ALLIANCE AGAINST WAR, Basel Switzerland ("Bündnis gegen Krieg, Basel Switzerland")
Project & Quality Management Experience Extract
Pharmaceutical Industry > 12 years experience
Date
(mm-yyyy - mm-yyyy)
Duration
(of
months)
Project / Operational
Role
Description 4
PM in QA/e-Compliance
Project Manager
Project Manager e-Archiving plant DEGE and Transfer to plant DEBA QA Manager Parenteral Manufacturing and PST 4
QM Roll-out Project ,
Novartis
QM Manager
Roll-out Application Migration GIS / IGM 7
Dev QA - QSS
Training Roll-out, Novartis
Business
Analyst
Roll-out, Validation, Training, Operational support for Global Pharma Development Global roll-out AQWA QE for Pharma Development, Novartis Roll-out, Validation, Training, Operational support for Global Pharma Development 9
DRA Quest report RegCMC crossover departments DRA to Supply Chain, Novartis
Business Analyst
Running and Analyzing the DRA Quest report for RegCMC from data sourcing to KPI 14
Qualification of a global IT Infrastructure, Novartis, TechOps
Project Quality Manager
New server landscape qualification and new service implementation, as well as Software, Configuration and Data Base move. Business Analyst/ Quality 4
Global roll-out in Roche, pRED
Business Analyst/
Quality
Roll-out Mosaic product for business process management. Set-up a Global Rollout Strategy, as well as Quality and Process Manual. Consult and support Local and Rollout Team in Quality and Process Issues. Business Analyst/ Quality LeadLab03 Project, Validation and Quality Assurance for Audit SAS and Statistical Tools - Competence Center, Novartis Project Manager/Quality Manager/ Solution Architect /Business Analyst Validation of all statistical tools. Competence Center Responsible. New Projects implementation. Responsible for deviation reporting, deviation impact assessment, corrective and preventive action analysis, as well as deviation investigation reporting Business Analyst/ Quality Validation of CTMS e-Siebel product for business process management. Business Analyst/ Quality Roll-out of different SAP projects Business Analyst/ Quality / Tester Sandoz - Pharma
Novartis - Pharma
Business Analyst/
Quality / Tester
SAS Migration from MVS to Unix
Core responsibilities & achievements
Innovatively leading and managing projects in multiple locations.
Trouble shooting key bottlenecks in Quality Management & Delivery process globally.
Determine new methods & develops new procedures based on the requirements of a situation
Designing a new Test Management Procedure for documentation that brings improvement of the system to meet compliance with Novartis and Roche, SOX & GxP (e.g. FDA, EMEA, GAMP5) regulatory requirements.
Managing the results of quality & testing teams to ensure compliance with ICE methodology.
Accountable for project deliverables (Validation/Quality/Project Plan, Test Strategy & Test Plan)
Conducting quality reviews to evaluate if process & deliverables fulfill the requirements for quality assurance & testing.
Managing Business Process Analysis & Modeling - Business Guidance Author.
Project communication to key stakeholders and ensuring that project quality targets were met in budget and time constraints.
Conducting steering committee and team meetings, trainings (Testers training) & assessments (Functional or Project Risk Assessment, Business Impact Assessment).
Documentation Management - writing & approving validation documents, preparation of project-related documents for final approval, publishing documents in SharePoint.
Configuration & Change Management - Establish & maintain consistency of the system to track & control changes.
Johnson & Johnson
GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
Boehringer-Ingelheim
IDEA Training - DocCoordinator Rolle, Biberach Germany 2016
LOS Training (SOPs QA/QC/QS)
SAP CC (Change Control)
Novartis Training Extract Sandoz QA / e-Compliance Training, 2016
GIS / IGM QM Trainings 2014, Novartis Basel Switzerland 2014
Development QA updated Trainings, LMS, Novartis Basel 2014
Computer System Regulations: EU Annex 11, 21 CFR Part 11 Novartis Basel, Switzerland 2013 LMS Administrator Training Enterprise Architecture Training, Novartis Basel Switzerland, 2012 ICE Bronze (Project Management) Training, 2008, 2010 DocNav (Document Management Platform) Training, 2011
ESOPS (Document Management Platform) Training, 2009
Diary (Document Management Platform) Training, 2008, 2010, 2011 Novartis Dev IT, EWS WebSDG, TechOps SOP & WP Trainings More detailed information available on request. GMP - Auditor Lead Training Program (external & internal) TrackWise - DMS, Change, CAPA - modules - QA Manger Role
PAQ and CSV - Quality Management Program
Pharma Standort Technical - Quality Management Program
Utilities (Pharmaceutical Water & Gaze) -Quality Management Program
Optical Control Parenteral -Quality Management Program
QC (Quality Control) Microbiology - Deputy Quality Management Program
PK / PDKS / SPS -Quality Management Program
HP Service Manager - Quality Manager
ELVIS - Engineering QA Manager Role
SAP QM - Quality Manager
SAP MM, PM, FI, CO -Program
PK / PDKS / SPS -Quality Management Program
Liquids and Lyophilisation - Deputy Quality Management Program
QE - Quality Assurance Engineering for Kaiseraugst
ConDor Training - Quality Manager Role
PT Risk Manger Training - Quality Manger Role
CTMS (Clinical Trial Management System) -Business Program
PTQBFB_001: Bundesgesetz über Arzneimittel und Medizinprodukte (HMG, Schweiz)
PTQBFB_002: Verordnung über die Bewilligung im Arzneimittelbereich (AMBV, Schweiz)
PTQBFB_003: EU GMP-GUIDE
PTQBFB_004: FDA Current GMP in Manufacturing, Processing, Packing or Holding of Drugs, 21 CFR part 210
PTQBFB_005: FDA Current GMP for Finished Pharmaceuticals, 21 CFR Part 211
PTQBFB_006: FDA Guidance for Industry: Q9 Quality Risk Management
PTQBFB_007: FDA 21 CFR Part 11 Final Rule
PTQBFB_008: FDA Guidance for Industry Part 11, ER, ES -Scope and Application
PTQBFB_009: FDA General Principles of Software Validation; Final Guidance Industry& FDA Staff
PTQBFB_010: FDA / ORA CPG 7132a.11 Compliance Policy Guide 425.100 Computerized Drug, CGMP Applicability to Hardware and Software
PTQBFB_011: FDA / ORA CPG 7132a.15 Compliance Policy Guide 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs
PTQBFB_014: PIC /S Guide to GMP of Medicinal Products
PTQBFB_015: PIC /S Guidance Good Practices for Computerized Systems in regulated "GxP" Environments
PTQBFB_016: EU Guidel., GMP Medicinal Products, Human &Veterinary Use EudraLex Vol 4-Part 1
PTQBFB_017: EU Guidel.. GMP Medicinal Products, Human &Veterinary Use EudraLex Vol 4-Part 2
PTQBFB_018: EU Guidelines to GMP Medicinal Products for Human and Veterinary Use EudraLex Volume 4 - Annex 11
PTQBFB_019: EU Guidelines to GMP Medical Products for Human and Veterinary Use EudraLex Volumen 4 - Annex 15
PTQBFB_020: Pharma Manufacturing Standards
PTQBFB_023: FDA Guidance Aseptic Processing
PTQBFB_024: EU Guidelines to GMP, Manufacture of Sterile Medicinal Products - Annex 1
Training to MHRA - Data Integrity Guide Pharmaceutical, Novartis AG Pharmaceutical, Novartis AG, Basel Switzerland
(more than 10 years work experience ) Pharmaceutical, Hoffman-La Roche AG Pharmaceutical, Hoffman-La Roche AG, Basel Switzerland
(more than 7 years work experience) HP Service Manager - Quality Manager Lean & Six Sigma Methodologies used in different projects cross over departments
SOP-Standard Operation Procedure Quality Review and Approval
Process Flow Compliance in Biological Product Manufacturing
QA Manager for Utilities Basel (Pharmaceutical Mediums, Gaz, Water, Energie) PST 'Pharma Standort Technik' Quality Assurance Manager ALLIANCE AGAINST WAR, Basel Switzerland ("Bündnis gegen Krieg, Basel Switzerland")
Project & Quality Management Experience Extract
Pharmaceutical Industry > 12 years experience
Date
(mm-yyyy - mm-yyyy)
Duration
(of
months)
Project / Operational
Role
Description Attachments
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