Freelancer Detail | GMDP.Expert

GMDP-0091

Senior CSV Validation Consultant

Disponible

Années d'expérience

Computer System Validation

Spécialisation

Royaume-Uni

Localisation

À propos de cet expert

Senior CSV Validation Consultant with 9+ years in pharmaceutical, biotech and GMP manufacturing. Expert in GAMP 5, Annex 11, 21 CFR Part 11, IQ/OQ/PQ, data integrity, PLC/HMI validation and risk-based lifecycle strategies.

Compétences

Expert

Computer system validation Data Integrity IQ/OQ/PQ Validation

Avancé

Equipment qualification Facility qualification Process validation CAPA Management Change Control Deviation Management SOP Writing & Review

Intermédiaire

Analytical testing Regulatory inspection support

Certifications

ECA Computer Validation Course – Introduction to Risk Management and the GAMP 5 Approach

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