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.