Freelancer Detail | GMDP.Expert

GMDP-0042

Validation Project Manager

Im Einsatz

Jahre Erfahrung

Validation / Qualification

Spezialisierung

Frankreich

Standort

Über diesen Experten

Senior GMP Validation & Quality Consultant with 18 years of experience in pharmaceutical manufacturing. Expertise in Cleaning Validation (CV), Process Validation (PV), Equipment Qualification (IQ/OQ/PQ), HVAC qualification and GMP Quality Systems. Experienced in Validation Master Plans (VMP), protocol development, risk management, CAPA, audits and cross-functional project leadership. Committed to delivering compliant, risk-based and efficient validation strategies in highly regulated GMP environments.

Kompetenzen

Fortgeschritten

IQ/OQ/PQ Validation Method validation Oral solid dosage CAPA Management Change Control Deviation Management Internal auditing Regulatory inspection support SOP Writing & Review Cleaning Validation Facility qualification

Mittelstufe

API Manufacturing GDP (Good Distribution Practice) Computer System Validation Data Integrity Inhalation & nasal Liquid & semi-solid Computer system validation Packaging Annual Product Quality Review

Grundkenntnisse

Sterile manufacturing

Zertifizierungen

Six Sigma — Yellow Belt (2025-12-01)

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