Executive, IPQA

Amneal Pharmaceuticals · Ahmedabad

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.Pharm/M.Pharm Total Experience - 3 - 4 Year inexperience in in-process Quality assurance for sterile manufacturing area. Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role.

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