Officer, IPQA
Amneal Pharmaceuticals India · Remote
Source and collection record
Last observed by our collector: . This is not a manual review or a confirmation from the employer.
Employer requisition: 8908
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Collected role description
Pharmacy graduate/post graduate with Minimum 1-3 year experience in IPQA function. 1 cGMP and compliance review in the GMP area as per cGMP guideline. 2 Machine and area clearance. 3 Sampling of blend, intermediate stages, AQL finished product, ANSI sample, reserve sample, stability sample and In-process checks during execution of batch manufacturing & Packaging as per Process Study Protocol (PSP), Process Validation Protocol (PVP), Batch Manufacturing Record (BMR), Batch Packaging Record (BPR) & miscellaneous protocol based study. 4 Issuance of Bottle label, Outsert and Medication guide for commercial batch. 5 Documents and records review like equipment logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record etc. 6 Calibration of IPQA instruments. 7 Supervision of dispensing activity of raw material and packaging material. 8 Review of executed Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR) and release for next stage.
Collected minimum qualification
Education: B. Pharm - Required M. Pharm - Preferred 2 years or more in 2 - 5 Years Specialized Knowledge: Licenses:
Collected experience requirement
2-5 years