Freelancer Detail | GMDP.Expert

GMDP-0077

Senior Corporate Quality Assurance Manager

Verfügbar

Jahre Erfahrung

Quality Assurance

Spezialisierung

Indien

Standort

Über diesen Experten

Senior QA Leader & ISO 9001 2015 Lead Auditor with 11+ years in OSD and sterile/injectable pharma. Expert in GMP compliance, regulatory inspections (USFDA, MHRA, EMA), data integrity, CAPA, and multi-site QMS governance.

Kompetenzen

Experte

Internal auditing Supplier Auditing GMP Auditing

Fortgeschritten

Change Control Deviation Management Computer system validation Oral solid dosage Sterile manufacturing Regulatory inspection support Data Integrity CAPA Management SOP Writing & Review Annual Product Quality Review

Mittelstufe

Process validation Out-of-Specification (OOS) Investigation

Zertifizierungen

CQI/IRCA Certified ISO Lead Auditor – ISO 9001:2015 Graduate Pharmacy Aptitude Test (GPAT) LinkedIn Learning – Certificate of Excellence

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