Job highlights

- Responsible for Process validation,cleaning validation / verification,hold time study,media fill routine batch sampling as per protocol / SOP
- Responsible to perform the in-process test at different stages as per batch document / SOP
- Note: Candidates who want to apply for internal jobs,must have completed atleast 2 years within existing role
- Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing.
- Responsible for Process validation, cleaning validation/verification, hold time study, media fill routine batch sampling as per protocol/SOP.
- Responsible for review of executed BMRs and BPRs.
- Responsible to perform the in-process test at different stages as per batch document/SOP.
- Responsible to review the different type of planner and calibration certificates.
- Responsible to monitor cGMP compliance at shop floor.
- Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc..
- To maintain the Issuance/reconciliation record of items / media for Workplace monitoring material e.g., plates, swabs,



etc..
- Responsible to participate in media fill simulation study.
- Responsible to participate in perform qualification activities of manufacturing area.
- Review of Media fill CD. Review of Visual inspector qualification record.

Skills
- In-Process Quality Controls (IPQC) Sampling - Practitioner
- Aseptic Process Simulation (Media Fill) Monitoring - Expert
- Line Clearance Batch Record Review - Practitioner
- Good Documentation Practices (GDP) - Practitioner
- Regulatory Compliance Knowledge - Practitioner

Education: B.Sc./ M.Sc/ B.Pharma / M.Pharma Total Experience - 1 - 6 Year inexperience in IPQA / Environmental Monitoring for sterile manufacturing plant

Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Executive, IPQA (Sanand)
🏢 Amneal Pharmaceuticals
📍 Sanand