Freelancer Detail | GMDP.Expert

GMDP-0039

QA Compliance Specialist

Beschikbaar

Jaren ervaring

GMP & GDP

Specialisatie

Nederland

Locatie

Over deze 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.

Competenties

Expert

GDP (Good Distribution Practice) GDP Compliance

Gevorderd

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

Gemiddeld

Cold Chain Management Packaging Controlled substances / narcotics Stability Study Design & Execution Annual Product Quality Review Sterile manufacturing Regulatory Submissions Equipment qualification

Certificeringen

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

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