Quality Assurance Executive

Position : Executive ( Lab QA)

Job Location : Tarapur

Job Profile:

1. Preparation and review of department SOPs.

2. To ensure GMP compliance in quality control laboratory.

3. Handling of deviations and ensure they are investigated and resolved.

4. To review and approve changes that potentially impact intermediate or API quality.

5. Preparation and review of Risk assessment done associated with the changes proposed or wherever applicable.

6. To review Corrective action and preventive action and its effectiveness.

7. Out of specification & Out of Trend investigation report review and its closure as per the respective SOPs.

8. To review all quality related documents.

9. To perform daily QC round to ensure compliance of online activities inline with cGMP and GLP.

10. To Review Analytical method validation / Verification and method transfer protocols and reports.

11. Reviewing completed batch production and Analytical test data sheets before release of finished products and intermediates and stability data.

12. Monthly audit trail verification and Electronic data verification & Random data verification of QC electronic data.

13. To review all specifications & testing procedures and test data sheets for Raw materials, Intermediates, Finished products, stability, in process and Pacing materials.

14. To ensure quality control specifications and analytical methods are confirming to the latest Pharmacopoeia & customer requirements.

15. To review all procedures impacting the quality of intermediates or APIs.

16. Ensure that internal audit (self-inspections) is performed and compliance of observations has been investigated and to ensure CAPA implementation and its effectiveness.

17. To Ensure that quality related complaints are investigated and resolved.

18. To Ensure that there is stability data to support retest or expiry dates and storage condition on APIs & Intermediates where appropriate.

19. To perform & review product quality review.

20. To Ensure execution of GMP training programs and departmental SOP training.

21. To Ensure the job related training for subordinates and ensuring the documentation & job descriptions review.

22. To ensure & execute retention samples are handled as per the SOP.

23. To ensure stability samples are charged, incubated, withdrawal and tested as per SOP. To ensure & execute the compliance of stability samples as per SOP.

24. To review and approve the qualification protocols and reports (DQ, IQ, OQ and PQ).

25. Response to Regulatory Affairs Department as applicable and submission of required data.

26. Release of API / Intermediate batches.

27. To perform and review Incubation, withdrawal and reconciliation activity of stability & Hold time samples in SCM software.

28. To Prepare & reviewMonthly and annually schedule of stability & Hold time study samples.

29. To maintain & review records of daily monitoring temperature & humidity of stability chamber.

30. To initiate,review of QMS in Track wise software.

Any other work allotted by the Head of the department

Experience : Minimum 4-5 Years

Qualification : BSc/ M Sc

Exposure of USFDA/EDQM Inspection.