QA - Sr. Officer /Executive (API Pharma Plant)

Role & responsibilities

1. Preparation of COA for Dispatch of APIs and Excipients.

2. Reviewing of completed Batch Production Records and laboratory records (Test data sheet). Distribution and Release of batches.

3. Review and Approval of validation/qualification protocols and reports.

4. Preparation and Review of change control that potentially impact intermediate or API quality.

5. Formal investigation of laboratory incidents, deviation and out-of-specification laboratory results and documentation.

6. Investigation of Market complaints, Market returns and Product recalls.

7. To give proper training of GMP and of other subjects to all related employees.

8. Review and qualification of any new vendors for the supply of key raw materials and packaging materials.

9. Reviewing all procedures impacting the quality of intermediates or APIs.

10. Making sure that critical deviations are investigated and resolved.

11.To ensure the all activities related to the product quality are complying.

12.To prepare Review and update the site master file, Validation master plan, requalification of plant equipment.

13.Inspection of plant, Quality Control as well as other department where ever necessary.

14. Qualification of the vendors of key raw materials and packaging materials

15. To review schedule for vendor audit and plan accordingly.

16. To plan and segregate the work to Subordinates

17. To prepare the annual product quality review

18. Making sure that there is stability data to support retest or expiry for the products.

19.To ensure that the system are used for maintaining and calibrating critical equipment/instrument.

20.To prepare the technical document for overseas registration.

21.Making sure that the effective systems are used in QC, production and warehouse.