Deputy Manager - QA

1. Responsible for maintaining GLP and GDP in QC department.
2. Review of SOPs, Specifications and STPs.
3. Identifying training needs of the staff in the QC department.
4. Ensuring that all Analytical Instruments are in good working condition
5. Ensure and maintain AMC / Calibration / Qualification schedule and status of QC Instruments / Standard Weight and other measuring instrument and timely completion of the same as per the schedule.
6. Up keeping the laboratory all the time ready for regulatory and customer audits.
7. Responsible for QC QMS Activity i.e Lab Incident, Deviation, OOS, OOC, CAPA for their timely initiation, investigation and closer.
8. Compliance for maintaining Working Standard and Reference Standard in the lab.
9. Ensure and verification of Log Books / Analytical Documents and online documentation in the lab.
10. Compliance for Columns / Chemical / Volumetric Solution / Reagent Solution management 
11. Compliance for Instrument Tags / Labels/ QC Status Board / NABL analysis
12. Responsible for maintaining and continuous improvement as per ICH Q7 A and relevant regulatory guidelines. 
13. Ensuring a safe environment is maintained in the laboratory.
14. Regularly provide the training to the QC Colleagues on SOP, GMP and GLP.
15. Ensure the Analytical Method validations as well method transfers are conducted with an approved protocol and duly documented and approved.
16. Present GLP and GMP related activities in the weekly review meeting and monthly review meeting to the Senior management.
17. Regularly supporting and providing the data as per the requirement from customer and regulatory.
18. Develop & prepare work procedures to minimize OHS risks and Adverse Environmental Impact.
19. Involve the regulatory and customer audits to provide the answers for queries 
20. Ensure the data integrity checks are conducted regularly to evaluate the health of the Quality system and implement actions as required.
21. Control and issuance of loose formats and hard books.
22. Preparation and review of Standard Operation Procedures, Specification, Test method and Quality control procedures.
23. Responsible for review and release of batches-QC analytical Documents.
24. Responsible for approval and release of products for Dispatch.
25. As and when additional responsibilities arise, same shall be taken based on the requirement.