Manager

Job Summary

1. Responsibility for all Finish Products, RM and stability activity in Quality control Lab.
2. Planning & work allotment for Finish Products, RM and Stability.
3. Change Control/Deviation/CAPA management w.r.t. quality control activity and ensure timely closure in trackwise.
4. To ensure compliance of global CAPAs.
5. To review and ensure compliance of internal /external audit points and ensure timely closure.
6. To ensure training of all QC employees in time as per training matrix.
7. Review of SOPs/ STPs/ Specifications before approval in EDMS.
8. Issuance of all QC related formats/annexures.
9. To support the internal audit/Regulatory/FDA audit with best of practices
10. Following all regulations of cGMPs as per schedule M.
11. To maintain the safety procedure in handling analytical equipment and hazards
12. Completing the training assigned as per the training need identified by participating in trainings organized or self-reading and provides training to all employees.
13. To follow the procedure of good documentation and recording of result as per SOP on GDP and good execution of laboratories practices.
14. To maintain and execute the analytical equipment s qualification (IQ, OQ & PQ) and CSV activity, maintained their related document and laboratories in good state of operation.
15. Planning & review of working standard, impurities/Reference standards, column, reagent, chemicals, and glass ware etc.
16. Planning & review calibration and preventive maintenance of lab instrument / equipment s as per the calibration scheduler & maintain calibration /PM scheduler.
17. To coordinate & planning of external calibration, instrument breakdown, Preventive maintenance as per scheduler.
18. To maintain and review the analytical equipment s qualification (IQ, OQ & PQ), maintained their related document and laboratories in good state of operation.
19. To prepare instrument method in Instruments/Equipment s as privileges assigned.
20. To follow procedure for non-conforming result as it is applicable in SOP of Lab Incident & OOC.
21. Working standard and sample release through LIMS and SAP.
22. To maintain the analytical equipment s and laboratories in good state of operation.
23. Assist in developing and updating SOPs, work instructions, forms, etc. related to Documents Management.
24. Maintain the instruments and laboratories in all time readiness.
25.  Responsible for any assigned activity by HOD.