Freelancer Detail | GMDP.Expert

GMDP-0081

Quality Assurance Manager / Senior Quality & Regulatory Affairs Leader

Disponible à temps partiel

Années d'expérience

GMP & GDP

Spécialisation

Émirats arabes unis

Localisation

À propos de cet expert

Senior pharmaceutical quality leader based in Dubai, with over 12 years across GMP manufacturing and GDP distribution in the UAE. Currently UAE Responsible Person for GDP at a regional distributor, managing quality technical agreements, health authority interface, and complaint/FSN handling for global principals. Led a 52-person QA team through a quality culture rebuild following a regulatory import ban, passing 11 health authority audits with zero critical observations. IRCA-certified ISO 9001:2015 Lead Auditor and Lean Six Sigma Green Belt. Recently authored the URS and led the multi-vendor evaluation for a new eQMS on SAP S/4HANA. Open to interim QA leadership, contract GMP/GDP audits, and eQMS advisory, remote or short on-site.

Compétences

Expert

GDP (Good Distribution Practice) Batch Release GDP Compliance

Avancé

Change Control GMP Auditing Internal auditing Supplier Auditing Cold Chain Management Cold chain / temperature-controlled logistics Computer system validation Process validation Sterile manufacturing Oral solid dosage Out-of-Specification (OOS) Investigation Annual Product Quality Review Regulatory inspection support SOP Writing & Review SOP Writing & Review CAPA Management Deviation Management IQ/OQ/PQ Validation

Intermédiaire

Packaging Regulatory Submissions

Certifications

ISO 9001:2015 Certified Lead Auditor Lean Six Sigma Green Belt Diploma in OH&S (OHSAS 18001) & Environmental Control (ISO 14001) Train the Trainer — Certified Coach

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