Job Description

1. To perform Machine and area clearance during dispensing, manufacturing and packaging operation.
2. To perform sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in-process samples and to manage sampling aids.
3. To carry out in-process checks, AQL and ANSI Sampling as per respective documents viz. protocol, BMR, BPR, SOPs and other GxP documents.
4. To ensure GMP practices at manufacturing shop floor.
5. To verify raw material dispensing activity.
6. To approve batch coding details during packaging operation.
7. Review of executed batch records and release for next processing stage.
8. Preparation and review of CPV data trend.
9. To perform impact assessment of breakdown memo.
10. To initiate change control, unplanned and planned deviation where ever required.
11. To review area, equipment and cleaning log and to ensure proper labelling.
12. To review environmental monitoring record, calibration records and executed Batch Manufacturing and packaging Records and respective electronic records.
13. To perform calibration of IPQA instruments.
14. To ensure appropriate labelling during manufacturing and packaging.
15. Storage, handling and dispensing of printed packing materials.
16. To review and approve packaging artworks, proofs and shade cards.
17. To archive executed documents like BMR, BPR, Hold time Protocol etc.
18. To review and approve the Quality Notification (Viz Change control and Deviation) during Batch Manufacturing/packaging.
19. To monitor and record the environmental condition of label control room.
20. To prepare and revise functional SOPs, wherever required.
21. Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HOD'S instructions and guidance.

Qualifications for Internal Candidates should completed the B. Pharm or M. Pharm or M.sc with minimum 1 year experience.

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.