Executive - QA

About the role

We are seeking an Executive – QA to lead quality assurance activities on the shop floor of a pharmaceutical manufacturing site. The role ensures strict adherence to batch records, SOPs and cGMP standards throughout the production process.

Key responsibilities

• Ensure compliance with batch records and SOPs for all products.
• Perform line clearance, in‑process checks and sampling to prevent mix‑ups, contamination and cross‑contamination.
• Review stage‑wise batch records and support timely product release.
• Prepare, execute and compile process performance qualification and cleaning validation studies.
• Review master batch manufacturing records and packing records in SAP.
• Participate in equipment qualification, calibration and periodic APQR preparation.
• Manage CAPA, change controls, OOS/OOT investigations, laboratory incidents, market complaints and deviations via QAMS.
• Coordinate self‑inspection activities and document observations.
• Lead investigations of product or system failures and provide training on cGMP requirements.
• Support batch release activities and handle eDMS and IPQA documentation.

Required profile

• 6‑9 years of experience in pharmaceutical quality assurance.
• Pharmacy degree (B.Pharm or equivalent).

Required skills

• SAP for batch record management.
• QAMS (Quality Assurance Management System) usage.
• eDMS (electronic Document Management System) handling.
• Process validation and cleaning validation expertise.
• CAPA management and change control procedures.
• Knowledge of cGMP regulations.