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Audrey HUMANN

neuilly sur seine

En résumé

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 seine 2010 - maintenant Ensure 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 seine 2009 - 2009 Quality Assurance Utilities/HVAC/Equipments Department.

Formations

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