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GMDP-0088

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

Available
11
Years Experience
GMP & GDP
Specialization
Malta
Location
About This 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.

Competencies

Expert
GDP Compliance Computer system validation GDP (Good Distribution Practice)
Advanced
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
Intermediate
Process validation Analytical testing

Certifications

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