Freelancer Detail | GMDP.Expert

GMDP-0088

EU GDP Responsible Person / Regulatory Affairs Officer / Pharmacovigilance Manager / CSV Expert / Medical Device Registered Person

Beschikbaar

Jaren ervaring

GMP & GDP

Specialisatie

Malta

Locatie

Over deze expert

EU Registered Pharmacist with 10+ years in Quality Assurance, Regulatory Compliance, GDP/GMP, CSV (Annex 11/GAMP 5), pharmacovigilance, and medical device regulatory frameworks. Currently acting as RP (GDP), MDR Registered Person, and PV Manager.

Competenties

Expert

GDP Compliance Computer system validation GDP (Good Distribution Practice)

Gevorderd

Pharmacovigilance QPPV CAPA Management Change Control Deviation Management Data Integrity SOP Writing & Review Batch Release Regulatory Submissions Regulatory inspection support Supplier Auditing GMP Auditing Medical devices & combination products Oral solid dosage IQ/OQ/PQ Validation Controlled substances / narcotics Internal auditing Cold Chain Management Cold chain / temperature-controlled logistics

Gemiddeld

Process validation Analytical testing

Certificeringen

EU GDP Responsible Person Medical Device Registered Person (MDR) Pharmacovigilance Manager / LCQPPV / EUQPPV Medical Devices Excellence Certificate

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