VJC Consulting - Founder
- Consultant Qualité - Qualified Person
2012 - maintenantRole of Qualified Person
Quality consultancy in the pharmaceutical and medical device sectors
Process improvement and harmonisation
Regulatory inspection preparation
Audits, training/coaching, KPI implementation, review of procedures, validation & qualification
Immunodiagnostic System
- Directeur Qualité Groupe
2010 - 2012Group quality strategy
ISO 13485 certification & FDA readiness
Process improvements & harmonisation
Audit & inspection management
Budget & people management
UCB
- Global GMP Quality Systems Manager
COLOMBES2006 - 2010Quality System maintenance
GMP processes improvement and harmonization
Policies and global SOPs implementation
Quality Software Tools configuration and implementation (e.g. TrackWise, eDMS)
Eli Lilly
- Quality Systems Pharm. Sciences R&D & Regulatory Compliance Assoc.
neuilly sur seine2002 - 2006Implementation of 2001/20/EC and Eudralex Vol. 4 annex 13 requirements
European CMO qualifications
Procedure and process improvement
GMP trainings
Audits
