We Sarthee Consutancy have an urgent opening for QA Department for our leading Pharma API Industry for Dahej Location

- Officer QA, M.Sc Chemistry Qualified (2 Openings)

1. 1-3 Years Experience

2. Preparation of Process and cleaning validation protocol and report.

3. Responsible for updation of validation master plan and Site master file.

4. Review of qualification documents.

5. Monitoring of calibration and preventive maintenance schedule.

6. Review and monitoring revalidation and requalification activity.

7. Monitoring of Factory Acceptance test (FAT) new equipments

8. Management of Qualification and validation documents.

9. Continue verification of validation batches and monitoring of validation recommendation.

10. Preparation of annual product review.

11. Responsible for reviewing for change control.

12. Plant round and monitoring of validation batches.

13. Preparation of SOP.

14. Review of Batch production and control records and equipment cleaning records

15. 2. Sr Officer QA(2 Openings) & Executive QA(1 Opening), M.Sc Chemistry Qualified

16. 3-6 Years, Salary Negotiable

17. Preparation and review of SOPs.

18. Handling of stability protocol, reviewing of stability data & report for stability study of product.

19. Review of Analytical test data sheets prior to batch release.

20. Review of the Analytical method validation / Method transfer documents.

21. Review of the Instruments Qualification documents.

22. Preparation & Review of Annual Product Quality Review of products.

23. Initiation of Change Controls.

24. Monitoring of in-process activity on shop floor for cGMP and SOP compliance.

25. To act as system administrator applicable to all computer systems attached with analytical instruments at site.

26. To create user ID in instrument systems software and groups defined as per user creation form in SOP.

27. Review of audit trials

Current Organization :
Current Designation :
Total Experience :
Notice Period :
Current location :
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Industry : Pharma / Biotech / Clinical Research

Functional Area : Production, Manufacturing, Maintenance

Role Category : Production/Manufacturing/Maintenance

Role : Quality Assurance/Quality Control Executive

Keyskills : Method Transfer Production Control Cleaning Validation Change Control Analytical Method Validation Product Quality Shop Floor Test Data Acceptance Testing Analytical Instruments

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