Quality Assurance Officer (Pharma)

About the role

The Quality Assurance Officer will support Lupin's manufacturing operations by ensuring compliance with SOPs and cGMP standards throughout the production and packaging processes. This role involves performing in‑process checks, sampling, and documentation review to guarantee product quality during validation activities.

Key responsibilities

• Conduct in‑process checks at various manufacturing and packaging stages.
• Perform sampling across all production phases.
• Prepare, execute, and compile process validation and cleaning validation reports.
• Participate in qualification, calibration, and equipment verification activities.
• Review master batch manufacturing records and batch packing records in SAP.
• Investigate product or system failures and support root‑cause analysis.
• Prepare APQR and validation qualification protocols.
• Link BMR, BPR, and TDS results in the SAP system.

Required profile

• Minimum 3 years of experience in Pharma Quality Assurance.
• Familiarity with pharma formulation production operations, cGMP documentation, batch records, and APQR.
• Graduation in Pharmacy.

Required skills

• SAP
• cGMP compliance
• Process validation
• Cleaning validation