Freelancer Detail | GMDP.Expert

GMDP-0071

Senior Consultant for Life Sciences / Qualified Person (QP/RP)

En mission

Années d'expérience

GMP & GDP

Spécialisation

Belgique

Localisation

À propos de cet expert

Industrial pharmacist and certified QP/RP with 28+ years in biopharmaceutical and medical devices industries. Expert in GMP/GDP/ISO 13485, sterile manufacturing, QMS set-up, batch release, auditing, and facility start-up.

Compétences

Expert

GMP Auditing Supplier Auditing Sterile manufacturing

Avancé

Batch Release Process validation Facility qualification IQ/OQ/PQ Validation Regulatory inspection support Internal auditing Change Control Deviation Management CAPA Management Packaging SOP Writing & Review Liquid & semi-solid Oral solid dosage Controlled substances / narcotics GDP Compliance GDP (Good Distribution Practice)

Intermédiaire

ATMP

Certifications

Registered Qualified Person (QP) 6-Sigma Black Belt Mini-transformation Responsible Person GDP (RP GDP)

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