Site QA Lead (Biopharma)

Lead and oversee complete Quality Assurance operations for biopharmaceutical bulk manufacturing, Quality Control (QC), engineering, warehouse, and IT systems at the Bengaluru facility.

Review and approve critical GxP documentation including Standard Operating Procedures (SOPs), Master Batch Records (BMRs), batch release checklists up to drug substance stage, and validation protocols (URS, DQ, IQ, OQ, PQ).

Oversee the control, reconciliation, and documentation maintenance of Research, Master, and Working Cell Banks (MCB/WCB).

Direct site-wide QMS elements, managing Deviations, Change Controls, CAPAs, Out of Specification (OOS), and Out of Trend (OOT) investigations with robust root cause analyses.

Oversee execution and reporting for Process Validation (PV), Cleaning Validation (CV), Thermal Cycle Studies, Transport Validation, and Bioburden controls.

Serve as the primary site Quality interface for health authority inspections (CDSCO, NIB, international regulatory agencies) and customer audits, driving audit readiness and timely CAPA closures.

Supervise environmental monitoring (EMP) and water system trending, stability protocols, hold-time studies, Computer System Validation (CSV), and Annual Product Quality Reviews (APQR).

Coordinate periodic Plant Quality Review Boards, track site Quality Metrics via QMA applications, and maintain the target Site Quality Index for executive leadership reviews.

Manage and mentor the site QA team, fostering continuous technical capability upgrades and strict cGMP adherence.