Executive – In-Process Quality Assurance (IPQA)
Amneal Pharmaceuticals · Ahmedabad
Job description
About the role
The Executive, IPQA ensures day‑to‑day compliance with global Good Manufacturing Practices (GMP) during manufacturing, packing, and dispensing activities. Working on the shop floor, you will support quality‑assured operations, protect product integrity and patient safety, and help maintain inspection readiness.
Key responsibilities
- Perform In‑Process Quality Assurance (IPQA) activities during manufacturing and packing.
- Oversee calibration of IPQA instruments and execute line clearance and readiness checks.
- Review and release batch records, including COA, BMR and BPR, ensuring data integrity.
- Conduct routine in‑process checks, environmental monitoring, and housekeeping record reviews.
- Support cleaning validation sampling, process validation reporting, and aseptic process simulations (media fill).
- Maintain Good Documentation Practices (GDP) and ensure compliance with 21 CFR Part 210 & 211.
- Participate in routine GMP inspections, quality record reviews, and investigations.
- Provide on‑the‑job GMP training to shop‑floor personnel and keep IPQA documentation audit‑ready.
Required profile
- B. Pharm (required); M. Pharm (preferred).
- 1 + year of experience in pharmaceutical manufacturing (1‑4 years total).
- Strong written and verbal communication skills in English.
Required skills
- Calibration of IPQA instruments.
- Line clearance procedures.
- Environmental monitoring.
- Batch record review and release.
- Cleaning validation sampling.
- Process validation reporting.
- Aseptic process simulation (media fill) monitoring.
- Good Documentation Practices (GDP).
- GMP compliance, including 21 CFR Part 210 & 211 knowledge.
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Published 2 weeks ago
Expires 1 month from now
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Amneal Pharmaceuticals
Ahmedabad