Quality Control Reviewer

Role & responsibilities

1. To ensure cGLP and cGMP compliance in Quality Control department

2. Planning and assigning work to the staff and ensure it is carried out as per the standard operating procedures.

3. Preparation and monitoring of specification of In-process and Finished product.

4. Monitoring of all the activities carried out in Quality Control department.

5. To ensure that all necessary testing of In-process and Finished products are carried out as per authorized specification.

6. To ensure the maintenance of the department, premises and equipments.

7. Responsible for review and approval of Quality Control Reports

8. Responsible for monitoring and Handling of Out Of specifications.

9. Responsible for monitoring and Handling of Out Of trend and laboratory incidents.

10. To review design criteria for new laboratory equipment considering cGMP requirements, in co-ordination with engineering.

11. To monitor the storage conditions for materials and products.

12. To review validation protocols, validation reports and specifications.

13. To review the Standard operating procedures and ensure its implementation.

14. To involve in internal audits / self-inspections as per the schedules and monitor compliance of observation made in the internal audit and self-inspections.

15. To involve in various national and international audits and ensuring timely completion of corrective and preventive action.

16. To carryout investigation, identify root cause, prepare corrective and Preventive action plan for the audit observations and to ensure the compliance in coordination with other functional departments.

17. Co-ordinate with production and Quality Assurance personnel during validation studies.

18. To coordinate with investigation team for market complaints investigation.

19. Responsible for general validation activities of quality control function.

20. To ensure retention of documents.

21. Responsible for control samples and its up keep.

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