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Executive, IPQA
Amneal Pharmaceuticals, Inc.
Ahmedabad
Full-Time
3-6 Years experience
Description
- 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
Eligibility Criteria
- Experience: 3+ years
- Seniority: Mid Level
- Education: Bachelor's degree required
- Languages: English
About Amneal Pharmaceuticals, Inc.
Amneal Pharmaceuticals develops, manufactures, and markets generic and specialty medicines worldwide.