Executive- IPQA (DP QA)

Enzene; Chakan; On-site; INR 600,000 - 800,000; Full time

Job summary

Enzene in Maharashtra, India, is seeking an IPQA professional to perform line clearance activities for Fill Finish Grade Areas, document in-process quality checks, and conduct IPQA inspections in the Fill Finish department.

You will monitor batch manufacturing, aseptic operations, review GMP documents, participate in Media Fill activities, and ensure compliance with cGMP and SOPs as an IPQA representative.

Qualifications

• Experience in biosimilars or injectable manufacturing is preferred.

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 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 aseptic practices and contamination control.

Job description

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.