QA Officer

1. To adhere the cGMP system of plant.

2. Preparation and execution of protocols & reports for qualification & validation activities.

3. Qualification of the new equipments.

4. Qualification & Re-qualification of critical systems HVAC, Nitrogen, Compressed air, Pure steam, Equipments etc.

5. Review of calibration reports of equipment/sub equipments, gauges & devices etc.

6. Preparation and execution of Cleaning validation protocols and reports.

7. Review of qualification activity and documents of QC-equipments/instruments.

8. Preparation & execution of Aseptic process simulation (Media fill) activity.

9. To handle the QMS issues, documents and also its timely closure.

10. In absence of candidate, alternate person shall do the activity with co-ordination to reporting manager.

11. Any additional responsibility assigned by department Head/Designee.