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)
Demander des informations
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