Freelancer Detail | GMDP.Expert

GMDP-0032

Head of Quality Compliance / Pharmaceutical Quality & Compliance Leader

Verfügbar

Jahre Erfahrung

GMP - Good Manufacturing Practice

Spezialisierung

Indien

Standort

Über diesen Experten

Pharmaceutical quality & compliance leader with 22+ years in GMP/GxP-regulated manufacturing. Expert in FDA/EU/WHO GMP inspections, CAPA, data integrity (ALCOA+), validation, supplier auditing, and QMS governance. ASQ CQA, ISO 9001 Lead Auditor, Lean Six Sigma Black Belt.

Kompetenzen

Experte

GMP Auditing CAPA Management Deviation Management

Fortgeschritten

Change Control Data Integrity Out-of-Specification (OOS) Investigation Process validation Cleaning validation Equipment qualification Supplier Auditing Internal auditing Regulatory inspection support Computer system validation Method validation SOP Writing & Review Annual Product Quality Review API Manufacturing Oral solid dosage

Zertifizierungen

ISO 9001 Lead Auditor Lean Six Sigma Black Belt ASQ Certified Quality Auditor (CQA)

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