Title:  Senior Executive

Job Summary:          

1. Responsible all Activity related to GLP, raw material, packaging material.

Essential Job Functions:

1. Planning & work allotment for RM, GLP and packaging materials.

2. Review the Raw material data and packing Material data and release.

3. Assist in developing and updating SOPs, work instructions, forms, etc.

4.  To Review stability data in Stability system.

5. To release the packaging, raw material and finish product.

6. Change Control/Deviation/CAPA management w.r.t. quality control activity and ensure timely closure.

7. Preparation & Review of Specification / STP and SOPs of respective work area.

8. Monitoring of gowning and sanitation practices in area of operation.

9. Monitoring of compliance of standard operation procedure for operation of analytical instrument.

10. To follow the procedure of good documentation and recording of result as per SOP on GDP and good execution of laboratories practices.

11. To support the internal audit/Regulatory/FDA audit with best of practices

12. Following all regulations of cGMPs as per schedule M.

13. To maintain the safety procedure in handling analytical equipment and hazards

14. Completing the training assigned as per the training need identified by participating in trainings organized or self-reading.

15. To calibrate the analytical equipment’s as per the calibration procedure for assigned responsibility of calibration.

16. To maintain the analytical equipment’s and laboratories in good state of operation.

17. To follow procedure for non-conforming result as it is applicable in SOP of OOT, OOS and Lab Incident.

18. To follow the administrative procedure of compliance with respect to term and condition for attendance, leave and other benefits.

19. To ensure training of reporting employees and related documentation on time.

20. Responsible for work assigned by Head QC.