2. Issuing and receiving Standard Operating Procedures, Formats, Batch Production Records, Batch cleaning Records, Raw material, In-Process, Intermediate raw datas and maintain the logbooks.

3. Review of executed batch production records, Batch Cleaning records, Raw material, In-process, Intermediate, finished raw datas and archiving in systematic manner.

4. Review and ensure that the stability data, holding data supports to retest/expiry dates, storage on APIs and Intermediates.

5. Reviewing of method transfer/method verification/method validation related protocols, raw data, and report.

6. Reviewing of SpecMoA and related forms.

7. Issuing registers for all departments maintaining of records for the reconciliation.

8. Archiving and retrieval of all GMP documents and retaining the documents as per the requirements.

9. Reviewing of all new analytical methods Pertaining to all products.

10. Review of Microbial Results like Environmental monitoring, Water samples, Finished products.

11. Review of Pest control and Environmental Records..

12. Verification of Data retrieval activities.

13. Data adhering to data integrity of the company.

14. Making sure that Change controls are raised wherever necessary and approved by concerned departments and maintenance of Change Control logbooks and review histories for all documents.

15. Responsible for all departments approved documents distribution and retrieval of existing documents.

16. Reviewing of New process proposals, New Batch Production Batch Cleaning Records.

17. Review of Process Validation protocols Reports, drying validation protocols Reports, Cleaning validation protocols Reports, Equipment Qualifications Reports and maintaining validation logbooks.

18. Verify the Cleanrooms as per respective line clearance checklists.

19. Responsible for monitoring and recording of Finished Product Sampling and sealing activities

20. Receiving and reviewing of Purchase Orders and distribution of POs to concerned departments and release to products to market and maintaining the distribution records.

21. Preparation of Annual Product Quality Reviews.

22. To follow cGMP, cGLP Safety etc

23. Responsible for the change control management such as initiation and review of change control.

24. Responsible for the audit trail review.

25. Reviewing of calibrations related to all QC instruments

Qualification Groups

Graduation B.Sc

Post Graduation M.Sc

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Executive