Assistant Manager / Manager – Quality Assurance (QA)

Quality Management Systems (QMS): Lead and govern end-to-end QMS operations, ensuring thorough handling and timely closure of Change Controls, Deviations, CAPA, OOS/OOT investigations, Risk Assessments, and Annual Product Quality Reviews (APQR).

Document Review & Batch Release: Review and approve core quality documentation, including Standard Operating Procedures (SOPs), master specifications, qualification protocols, validation reports, and Batch Manufacturing/Packaging Records (BMR/BPR).

Audits & Regulatory Inspections: Serve as a primary QA coordinator for regulatory inspections (USFDA, EU GMP, WHO, PIC/S, etc.), customer audits, internal GMP audits, and external vendor compliance reviews.

Validation & Qualification Oversight: Direct qualification and validation lifecycles across the facility, covering Process Validation, Cleaning Validation, Analytical Method Validation (AMV), and Equipment/Utility Qualification (IQ/OQ/PQ).

External Partner & Vendor Governance: Oversee vendor qualification audits, external contract testing laboratories, and contract manufacturing organizations (CMOs).

Market Quality & Escalations: Manage customer complaints, product returns, failure investigations, and product recall procedures in full alignment with international guidelines.

Cross-Functional Leadership: Direct and mentor the QA operational team, working closely with Production, QC, Regulatory Affairs, and Supply Chain to drive continuous GMP compliance.