Freelancer Detail | GMDP.Expert

GMDP-0090

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

Verfügbar

Jahre Erfahrung

Qualified Person (QP)

Spezialisierung

Vereinigtes Königreich

Standort

Über diesen Experten

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.

Kompetenzen

Experte

Batch Release CAPA Management Change Control

Fortgeschritten

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

Zertifizierungen

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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