Freelancer Detail | GMDP.Expert

GMDP-0090

Senior Quality Leader | Qualified Person (QP) | Responsible Person / Responsible Person for Import (RP/RPi)

Beschikbaar

Jaren ervaring

Qualified Person (QP)

Specialisatie

Verenigd Koninkrijk

Locatie

Over deze expert

Senior pharmaceutical Quality Leader and QP with 25+ years in GMP/GDP/GVP compliance, batch release, global QMS governance, regulatory inspections, sterile manufacturing, biologics, ATMPs, and CMO oversight across EU/UK markets.

Competenties

Expert

Batch Release CAPA Management Change Control

Gevorderd

Deviation Management GDP (Good Distribution Practice) GDP Compliance GMP Auditing Pharmacovigilance QPPV Process validation Regulatory inspection support Regulatory Submissions Sterile manufacturing ATMP Biologics & biosimilars Supplier Auditing Internal auditing Medical devices & combination products Cold Chain Management Cold chain / temperature-controlled logistics Data Integrity Highly potent / cytotoxic Vaccines

Certificeringen

Qualified Person (QP) Responsible Person / Responsible Person for Import (RP/RPi) Lean Six Sigma Green Belt Registered Pharmacist Deputy QPPV Member – QP/RP Association Member – Royal Society of Chemistry ISPE Global Facility of the Year Award (FOYA) – Integration Category

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