Amneal Pharmaceuticals Released Job Openings On 17/06/2022.Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our nearly 6,000 colleagues are working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry.
Amneal Pharmaceuticals Recruiting B.Pharm/M. Pharm/ M.sc Microbiologist with 02 -07 years of Experience for Officer/Sr. Officer/ Executive/ Sr. Executive – QA Position.Complete Details for the Officer/Sr. Officer/ Executive/ Sr. Executive – QA as follows.
Important Details :
- No of Vacancies:15
- Details of SalaryNA
- Opening date for online Application: 17/06/2022
- Mode of application :Online
- How To Apply: Interested candidates can share resume on email@example.com
Job Description/Skills Required
We are looking for competent, dynamic and motivated candidates for suitable positions for Injectable unit for our Ahmedabad SEZ Matoda Plant.
1. Quality Assurance (Validation/IPQA/EM) – Injectable/Parenteral Unit)
Key area: IPQA, Line Clearance, BMR-BPR review, Aseptic area, Media fill, Environment monitoring, Plate settlement, Validation, qualification, Equipment qualification, Process validation, protocol preparation, etc.
- 1. Responsible for preparation, review and implementation of Standard Operating Procedures of Quality Assurance department.
- 2. Should have sound knowledge and experience in Environmental Monitoring (Air Sampling, Settle Plate, Surface Monitoring, Personnel Monitoring)
- 3. Responsible for the review of BMR/BPR.
- 4. Responsible for Document management like BMR, BPR, Master SOP, training record etc.
- 5. Responsible for reserve sample management, annual review and destruction as per procedure.
- 6. Responsible for tracking of stability sample collection as per protocol.
- 7. Responsible for stage wise line clearance activity before commencing the operations like dispensing, manufacturing, filling, Lyophilization, sealing, labelling and packing operations.
- 8. Supervision of sampling activity for in-process and finished samples for analysis and other samples requirement as per protocols (Process Validation, Cleaning Validation etc.)
- 9. Responsible to provide and fulfil the documents requirement of Regulatory Affairs department for filing or other requirements.
- 10. This includes documents review, protocol preparation, qualification executions and support to CFT and report compilation.
- 11. All the equipment qualification (URS, DQ, FAT) i.e. Filling line, Vessels, Packing machines, UAFs, DPBs, Mobile carts, documents review and approval etc.
- 12. All the utility qualification (URS, DQ, FAT, IQ, OQ, PQ) i.e. HVAC, Compressed air, Nitrogen gas, WFI (Phase I, Phase II, Phase III), PW (Phase I, Phase II, Phase III), Pure Steam, Smoke study, etc.
- 13. Media fills (All process i.e. Liquid, Suspension, Emulsion as applicable)
- 14. Process validation, cleaning validation, CEHT, DEHT
- 15. Facility qualification, FAT