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GMDP-0080

Freelance CQV Engineer / Consultant – Pharma & Life Sciences

Disponible
20
Années d'expérience
Validation / Qualification
Spécialisation
Allemagne
Localisation
À propos de cet expert

CQV Engineer with 20+ years in GMP-regulated pharma environments. Expert in DQ/IQ/OQ/PQ, cleanroom qualification (ISO 14644), HVAC, MEP interfaces, FAT/SAT, commissioning, and audit-ready GMP documentation.

Compétences

Expert
Facility qualification IQ/OQ/PQ Validation Equipment qualification
Avancé
Change Control Process validation SOP Writing & Review
Intermédiaire
CAPA Management Regulatory inspection support Deviation Management Vaccines Computer system validation

Certifications

GMP Training Cleanroom Technology / ISO 14644 GAMP5 Occupational Safety / PPE
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