Officer, Quality Assurance at Amneal India

, , India -

Full Time

Start Date

Immediate

Expiry Date

17 Jun, 26

Salary

0.0

Posted On

19 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Machine Clearance, Area Clearance, Sampling, In-Process Checks, AQL Sampling, ANSI Sampling, GMP Practices, Raw Material Dispensing, Batch Coding, Batch Record Review, CPV Data Trend, Impact Assessment, Change Control Initiation, Deviation Initiation, Environmental Monitoring, SOP Preparation

Industry

Pharmaceutical Manufacturing

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. 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.

Responsibilities

The role involves performing quality assurance activities across dispensing, manufacturing, and packaging operations, including performing clearances, sampling, and in-process checks according to GxP documents. Key duties also include reviewing executed batch records, managing quality notifications like change controls and deviations, and ensuring adherence to GMP practices on the shop floor.