Freelancer Detail | GMDP.Expert

GMDP-0039

QA Compliance Specialist

Verfügbar

Jahre Erfahrung

GMP & GDP

Spezialisierung

Niederlande

Standort

Über diesen Experten

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.

Kompetenzen

Experte

GDP (Good Distribution Practice) GDP Compliance

Fortgeschritten

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

Mittelstufe

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

Zertifizierungen

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

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