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GMDP-0039

QA Compliance Specialist

Disponible
11
Années d'expérience
GMP & GDP
Spécialisation
Pays-Bas
Localisation
À propos de cet expert

QA Compliance Specialist with 10+ years in pharmaceutical quality assurance across GMP and GDP environments. Expertise in CAPA, change control, supplier qualification, auditing, deviation management, and QMS maintenance.

Compétences

Expert
GDP (Good Distribution Practice) GDP Compliance
Avancé
Batch Release SOP Writing & Review Method validation Process validation Supplier Auditing GMP Auditing Internal auditing Regulatory inspection support Cold chain / temperature-controlled logistics CAPA Management Change Control Oral solid dosage Deviation Management Out-of-Specification (OOS) Investigation
Intermédiaire
Cold Chain Management Packaging Controlled substances / narcotics Stability Study Design & Execution Annual Product Quality Review Sterile manufacturing Regulatory Submissions Equipment qualification

Certifications

External audits & self-inspections GDP – Responsible Person Technology Transfer (2025-09-18)
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