Freelancer Detail | GMDP.Expert

GMDP-0031

Senior Quality Assurance Consultant

Disponible

Années d'expérience

GMP & GDP

Spécialisation

Pays-Bas

Localisation

À propos de cet expert

Senior QA Consultant with 20+ years in pharma/biotech. Expert in GMP auditing, supplier audits, equipment qualification, change control, deviation management, CAPA, and inspection readiness across EU/FDA frameworks.

Compétences

Expert

GMP Auditing Supplier Auditing CAPA Management

Avancé

Change Control Deviation Management Equipment qualification IQ/OQ/PQ Validation Internal auditing Regulatory inspection support SOP Writing & Review GDP Compliance Batch Release Process validation Biologics & biosimilars

Intermédiaire

Cold Chain Management API Manufacturing Computer system validation

Certifications

Responsible Person (EudraGDMP)

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