Senior Associate Quality Assurance - Contract Manufacturing, Eli Lilly and Company
Mes compétences :
GMP
GXP
Medical devices
Regulatory Affairs
Clinical trials
Entreprises
Eli Lilly
- Senior Associate Quality Assurance
neuilly sur seine2010 - maintenantEnsure Quality oversight for packaging operations of clinical trial material (CT packaging) done by Contract Manufacturers or partners, and their conformity with the Lilly Corporate Quality standards, local procedures, national and international regulatory requirements and GMP's.
GMP compliance and Batch Release (Packaging Operations).
Batch Records Review (for Packaging operations),
Events and Changes Management (DRB/CRB, CAPA, RCA Investigations, …),
Official trainer for the qualification to batch record review,
CMO (Contract Manufacturing Organization) oversight.
Eli Lilly
- QA rep
neuilly sur seine2009 - 2009Quality Assurance Utilities/HVAC/Equipments Department.
