QA Officer (Pharmaceutical Production)
Lupin · Sikkim
Job description
About the role
We are seeking a QA Officer to ensure strict compliance with batch records, SOPs and cGMP requirements on the shop floor of a pharmaceutical manufacturing site. The role involves monitoring processes, preventing mix‑ups and contamination, and supporting product release activities.
Key responsibilities
- Verify compliance with batch records and SOPs for various products.
- Maintain cGMP standards on the shop floor, including line clearance and contamination control.
- Perform in‑process checks and sampling at defined manufacturing stages.
- Review batch records stage‑wise to facilitate timely product release.
- Prepare, execute and compile process validation (PPQ) and cleaning validation/verification studies.
- Review master batch manufacturing records and packing records in SAP.
- Participate in investigations of product or system failures.
- Provide cGMP training and awareness to technicians.
Required profile
- 2‑4 years of experience in pharmaceutical quality assurance or related field.
- Graduation in Pharmacy.
Required skills
- SAP for batch record review.
- Knowledge of cGMP regulations.
- Process validation expertise.
- Cleaning validation and verification experience.
- Batch record review and documentation skills.
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Published 1 month ago
Expires 2 weeks from now
46 views · 0 interested
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Lupin
Sikkim