Title:  Executive

RESPONSIBILITY:

1. To manage activities of finished product & Stability section.
2. Provide leadership and direction to ensure the achievement of all finish product & Stability section.
3. Work allotment, sample management and timely analysis of commercial In-Process, validation, finish products & Stability Samples.  
4. Timely release of In-process, Validation and Finish Product samples.
5. To ensure completion of analysis of commercial stability samples within the window period.
6. Ensure compliance in testing and release for commercial stability and finished product as per cGMP standards.
7. To maintain SOPs related to finished product as per global quality standards and regulatory requirements.
8. To ensure date in, date out and inventories of stability sample in line with SOP.
9. To support QA systems and process related to data review.
10. To support regulatory operation for timely submission.
11. Responsible for laboratory investigation and root cause of OOS, OOT, deviation and implementation of CAPA accordingly.
12. Periodic review of related log books.
13. To ensure execution and review of protocols of calibration, mapping and qualification of stability chambers and other instruments.
14. Coordination for analytical method transfer and review of respective records.
15. Maintain and report quality matrices for commercial finish product and stability sections.
16. Monitor performance and set improvement areas.
17. Determine resource needs (staff, instruments, lab space etc.) and manage organizational development including interview and selection, mentoring, coaching, counseling and performance management of staff.
18. To impart training to QC users as per requirement.
19. Participate in all internal, external and regulatory inspections.
20. Maintain cGMP compliance in the working areas.
21. To ensure timely destruction of samples after completion of analysis.
22. To ensure qualification of analysts and competency matrices.
23. Responsible for effective managing the change control and quality risk management process at site & ensuring all requirements of the process are adhered to and providing approvals
24. Destruction of Stability / Finished Product/ Validation/In-process/Swab samples after completion of analysis and review of the data.
25. Ensure integrity, accuracy and adequacy of the analysis performed.
26. Recording of instrument and standard usage in the respective log books/registers.
27. To perform the analytical method transfer activity as and when required.
28. Preparation of eCOA /SAP COA/ Regulatory COA as per requirement.
29. Data punching in Novatek Software.
30. To correct the document observation on time given by QA of QC reviewer. 
31. Any other Assignment given by Lab in charge/ Manager Quality Control from time to time.
32. Conduct date-in, date-out and inventories of stability samples in line with SOP.
33. Daily monitoring of stability chambers.
34. Review calibration certificates, calibration and preventive maintenance record etc. for accuracy and completeness.
35. To prepare, execute and review protocols of calibration, mapping and qualification of stability chamber.
36. Ensure periodically qualification, calibration and preventive maintenance of stability chamber.
37. Ensuring all stability chambers qualified, monitored and suitable for intended use.
38. Performing samples receipt, incubation, withdrawal, inventory, and destruction.
39. Label printing, label pasting and bar code scanning, charging and withdrawal of stability samples.
40. Printing stability samples scheduler.
41. Physical inventory verification of charged stability samples.
42. Conducting the stability study as per approved stability protocol.
43. Ensure compliance to cGMP requirements and laboratories procedures.