About this 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 Environment 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.