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Executive- QA of Qc
5 months ago
**Title**:Executive
- QA of QC**:
- Date: Apr 5, 2024- Location: Mohali - Quality Assurance- Company: Sun Pharmaceutical Industries Ltd- 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
Empower.
- 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.