Role & responsibilities:

- Perform line clearance activities for Fill Finish Grade Areas, including manufacturing, filtration, filling, and sealing operations.
- Execute and document in-process quality checks at the Fill Finish shop floor.
- Conduct IPQA inspections in the Fill Finish department and follow up on corrective and preventive actions (CAPA) for identified observations.
- Monitor batch manufacturing and filtration activities to ensure compliance with approved procedures.
- Continuously monitor aseptic operations in Grade B Fill Finish areas to ensure adherence to aseptic practices and contamination control requirements.
- Review logbooks, batch records, and other GMP documents related to shop floor activities.
- Participate in, track, and update Media Fill (Process Simulation) activities and gowning qualification programs.
- Ensure shop floor compliance with cGMP requirements, approved Standard Operating Procedures (SOPs), and regulatory expectations as an In-Process Quality Assurance (IPQA) representative.

Preferred candidate profile:

- Candidates with experience in biosimilars and injectable manufacturing environments will be preferred.

📌 Executive- IPQA (DP QA) (Pune)
🏢 Enzene
📍 Pune