Senior Executive/Team Leader - Quality Assurance, API

1. To ensure that all the activities carried out as per approved standard operating procedures and regulatory norms.

2. To review the other department SOPs and ensuring the adherence to cGMP requirements.

3. To review Master Batch Manufacturing Records (MFRs, BMRs).

4. To review master analytical procedures and analytical records of intermediate and finished products.

5. To participate in the investigations at plant.

6. To participate in investigations like OOS investigations, GCPD, Deviation investigations. CAPA etc.

7. To participate in the Process Validation activities.

8. To initiate the Change Controls, SOP revisions.

9. To perform review and closure of all QMS events e.g. Deviation, Change control, OOS, CAPA etc

10. To maintain the documents and relevant logbooks e.g. Deviation, Change control, OOS, CAPA etc.

11. To prepare CAPA effectiveness.

12. To prepare APQR, Continuous process verification.

13. To give line clearance.

14. Distribution of all GMP documents.

15. To archive the master copies of Specification, Analytical procedures, production relevant master documents and master SOPs of all departments.

16. To issue the batch manufacturing record, Analytical Worksheets and its control.

17. Participate in all qualification and validation activities.

18. Co-ordinate with the regulatory department for the various changes proposed and seeking the approval on the same.

19. Support the customer and authority inspections and reply to various queries arising during the same.

20. Handling customer complaints.

21. To review the executed Batch Manufacturing Records.

22. Participating in various project discussions during that the facilities are designed and built as per requirement of cGMP.

23. To review the Analytical Reports.

24. To conduct training activities and fulfill the requirements of Training Administrator in Compliancewire.

25. To handle training activity via Trackwise.

26. To review dispatch activities.

27. To issuance documents to regulatory for filing and support other Solara location with respect to documents as and when required.

28. To carry out the work imparted by supervisor as and when required

29. To review Qualification and Risk Assessment documents.

Responsible to perform role as per EHS SOP during Emergency.