Title:  Executive- QA of QC

• Review  of Raw Material/Packaging  Material  /Stability/  Microbiology/  Cleaning Method Validation/ Validation/ Finished Product Analytical data, Certificate of Analysis & related documents.

•     Review and approval of Exhibit Stability Protocols.

•      Preparation and review of validation /pre-validation /commercial/annual addition batch/thermal excursion/additional study stability protocol.

•     Approval of additional testing requests (if required).

•      Review and approval of ln-Vitro/CU and dissolution sheets.

•      Review and approval of Analytical Method Transfer documents.

•     Participation in handling OOS, OOT, Investigation and deviations related to

Quality Control.

•      Review  and  approval  of weekly  and  monthly  software  verification  reports  of

Empower3.

•      Periodic  verification  of application  software  on computer  systems,  associated with laboratory instruments with system administrator.

•      Review of lab instruments calibration/preventive  maintenance data.

•      Review of Stability test results in NOVATEK software.

•     Approval of Certificate of Analysis.

•      Review and submission of analytical data to site regulatory affairs.

•     To  provide  the  response  of  regulatory  affairs  and  Office  of  data  reliability queries.

•      Review  and  approval  of change  control  request,  specification,  standard  test procedure and SOP in Documentum Compliance Manager System.