Manager - QC

1. Responsible to complete the work assigned and ensure the training on the activity which are assigned by supervisor/ HOD-QC prior execution.
2. Review of packing materials, raw materials, stability samples, in process and finished products data. 
3. Review Qualification, Validation, Calibration data, Procedure, Audit Trail on timely manner. 
4. To identify unsafe conditions/ acts inside the laboratory, report to supervisor/ HOD- QC and ensure its completeness.
5.   To receive and Inward the analysis sample includes packing materials, raw 
6. materials, In-process, Intermediate, API, Finished product, Stability samples and 
7. make entry in to the respective AR number logs.
8. To allocate work of chemical and Instrumentation area and Ensure timely completion of work. Ensure allocated work is inline with Analyst Qualification reports.   
9. Review QC Logs, Incidences, Reports and ensure document archival after released of samples.
10. Ensure Control sample inspection and Leftover sample disposal after analysis. 
11. Ensure Instrument calibration and AMC done as per the schedule.
12. Prepared and Revised SOPs, Specification and Procedure in line with Regulatory requirement. 
13. Conduct Training on SOPs, Trending and any other relevant procedure.   
14. Prepare Stability Schedule, Stability protocol and Report, Validation/ Qualification, Trending reports. 
15. Involved in Investigation and Ensure effectiveness of CAPAs. 
16. Performa SAP activity and Ensure closer of QMS before release of Batches in SAP. 
17. Actively involve during LIMS deployment, act as LIMS admin, aware about CSV 
18. LIMS data management, Mater data creator and static maintainer  for LIMS. 
19. Shall perform assessment,and supporting to investigations, deviations and implementing CAPA effectively.