Sr Executive / Assistant Manager - QA (IVD)

1. Responsible for implementation of cGMP in the plant.

2. Responsible for review of SOPs.

3. Responsible for preparation of Quality Documents such as SMF, Quality Policy etc.

4. Responsible for review and compilation of Deviations, Incidents, Change Control and Root Cause Analysis.

5. Responsible for review and proper implementation of CAPA.

6. Responsible for conducting and preparation of Self-inspection reports.

7. Responsible for handling of Market Complaints & Product Recall.

8. Responsible for providing trainings.

9. Responsible for approval of Certificate of Analysis, Specifications, STPs and SOPs.

10. Responsible for review of approved vendor list of Raw Material & Packing Material.

11. Responsible for review of Master Packing Card, Master Formula Card, Batch Manufacturing Records & Batch Packing Records.

12. Responsible for ensuring the Design and development processes meet regulatory and quality standards.

13. Responsible for risk management associated with IVD products.