Executive- IPQA (DP QA)

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.