IPQA Analyst

Role & responsibilities

1. Responsible for review of batch manufacturing and batch packaging record.

2. Responsible for QA oversight in production shopfloor.

3. Responsible for compiling the documents for batch release.

4. Responsible for verification of product dispatch checklist.

5. Responsible for review of APQR (Annual Product Quality Review)

6. To ensure Contamination control strategy in production shopfloor.

7. Responsible for impact evaluation of Contamination Control Strategy during change control evaluation.

8. To involve in investigation of market complaints, product recall and manufacturing related investigations.

9. Responsible for review of media fill simulation approach & protocol and report.

10. To involve in media fill simulation study for compliance with respective SOP, Protocol and CGMP.

11. Review of process validation, cleaning validation and Hold time study protocol and report.

12. Responsible for line clearance and process verification of manufacturing, filling & capping, visual inspection & packing activities.

13. Responsible for AQL verification in visual inspection Process.

14. Responsible for line clearance and verification of production process.

15. Responsible for In- process quality checks for stage wise process i.e. manufacturing, manufacturing, filling & capping, visual inspection & packing activities.

16. Responsible for sampling of process validation, hold time study, cleaning validation, stability study etc samples during respective production process.

17. Responsible for preparation and / review of Standard Operating Procedures.

18. Responsible for evaluation of change management system and adequacy of implementation.

19. Responsible for co-ordination and support to cross functional department for smooth operation.

20. To co-ordinate for preparation and or review of risk assessment and Contamination Control Strategy.

21. To ensure CGMP compliance and effective implementation of departmental procedures.

22. Responsible for review of relevant documentation, i.e. logs books, calibration records, preventive maintenance records etc.

23. To ensure overall Good Documentation Practices within the manufacturing facility.

24. Responsible for Continuous Process Improvement of the ongoing process, system and approach.

25. Responsible for GEMBA walk of shop floor for continuous improvements.

26. Co-ordination in new product introduction and related activities on shopfloor and documentation review.

27. To ensure Production and operational activities are following respective SOPs, CGMP and ALCOA principles.

28. Responsible to represent IPQA functions during regulatory audit and to involve in compliance with regulatory requirement.