Mes compétences :
GAMP
Analyse de risques
Quality assurance
Compliance
Assurance qualité
Pharmacovigilance
CSV
Entreprises
Assystem
Courbevoiemaintenant
ABBOTT Laboratories
- Global Quality Engineer
Rungis 2007 - maintenantValidation Team Lead on global project, QA Support to local organizations, Definition of corporate policies (pragmatic approach for Business Process Risk Assessment, Audit Trail Review and Periodic Evaluation)
Main Projects :
• Serialization Business Process Harmonization
• Global system for pharmacovigilance
• SAP
• Global System for learning management
• Clinical and safety data analysis tool
FOURNIER Laboratories
- Head of IT Compliance
2003 - 2007
Assytem
- Business Manager
1996 - 2003From Junior Consultant to Business&Technical Manager for the Strasbourg Agency (Pharmaceutical BU)
Validation&Compliance Services, manager of a team of up to 60 engineers and technicians, forecast and budget (5M€), recruitment, quotations and negotiations.
Validation Plan, DQ/IQ/OQ/PQ, process validation, CC management
Main Projects :
• Cooling loop - Cogema
• Preparation workshop for liquids – Janssen Cilag (Brazil)
• Inspection Equipment – Sanofi
• Y2K and Part 11 projects - Lilly
• Steam Sterilizer - Lilly
• Freeze drying line – Lilly
• Continuous Particle Monitoring –Lilly
• Global GMP upgrade – Octapharma
• QA/QC department reorganization – Octapharma (Sweden)