Officer, IPQA
Amneal Pharmaceuticals, Inc.
Description
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.
Eligibility Criteria
- Experience: 1+ year
- Seniority: Entry Level
- Education: Bachelor's degree required
- Languages: English
About Amneal Pharmaceuticals, Inc.
Amneal Pharmaceuticals develops, manufactures, and markets generic and specialty medicines worldwide.