QA Executive

1. To maintain and monitor cGMP in Plant.

2. Review of Quality Documents SMF, VMP, Quality Manual etc.

3. To conduct scheduled training and need base training to QA and other department staff.

4. Handling of change control, deviation, incident and CAPA.

5. Handling of Customer Audits, Regulatory Audits and Internal Audits.

6. To review audit compliance reports, associated CAPA and its implementation

7. Handling of Market Complaints

8. Handling of Product recall and Mock recall.

9. Assist in Root cause analysis and investigation of non-compliances.

10. Handling of OOS and OOT.

11. Risk assessment of Process, Equipment & Product.

12. Review of calibration reports of equipment/instrument, gauges and devices etc.

13. Review of preventive maintenance planner /calibration planner etc.

14. Review of qualification activity & documents of QC-equipments/instruments.

15. Review and execution of validation and qualification protocol and reports.

16. Review of Standard Operating Procedures, Specifications, BMR/BPR, MFR/MPR etc.

17. To recruit technical staff in QA department.

18. In absence of candidate, alternate person shall do the activity with co-ordination.

19. Any additional responsibility assigned by department Head.