Role & responsibilities:
1. Min.8-10 Year Experience.
2. Should have Graduate / Post graduate from reputed university.
3. Having minimum 6-8 year experience in API manufacturing in Quality Assurance. Preferably from Good/ Reputed API manufacturing company.
4.Should have familiar with USFDA and EDQM requirements.
5. Having experience of handling of CAPA/ Deviation, Risk assessment, Complaint handling, Change control system. Root cause Investigation.
6. Additionally he should have experience of Handling of OOS/ OOT and exposure of perform independent investigation with respect to OOS/OOT.
7.Handling of vendor qualification, preparation and review of BPR/Process validation & Cleaning validation.
8. Knowledge of preparation & execution of Process and cleaning validation.
9. Should have knowledge of SOP preparation.
10. Having experience of handling of CAPA/ Deviation, Risk assessment, Complaint handling & Change control system.
11. Knowledge of preparation & execution of Process and cleaning validation.
Preferred candidate profile:
- Candidate should be from reputed API / Worked in USFDA approved plant / should have knowledge of GMP.
Google Map Link - https://www.google.com/maps/dir//National+Highway+no.8,+near+Tejpal+Motors,+Balitha,+Vapi,+Gujarat+396191/@20.3912968,72.8296201,12z/data=!4m8!4m7!1m0!1m5!1m1!1s0x3be0cfc51619d3f7:0x54a5c456d3a2559e!2m2!1d72.9120218!2d20.3913162?entry=ttu
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