Freelancer Detail | GMDP.Expert

GMDP-0077

Senior Corporate Quality Assurance Manager

Disponible

Années d'expérience

Quality Assurance

Spécialisation

Inde

Localisation

À propos de cet expert

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.

Compétences

Expert

Internal auditing Supplier Auditing GMP Auditing

Avancé

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

Intermédiaire

Process validation Out-of-Specification (OOS) Investigation

Certifications

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

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