Freelancer Detail | GMDP.Expert

GMDP-0077

Senior Corporate Quality Assurance Manager

Available

Years Experience

Quality Assurance

Specialization

India

Location

About This 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.

Competencies

Expert

Internal auditing Supplier Auditing GMP Auditing

Advanced

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

Intermediate

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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