- Ensure the compliance with corporate policies (Quality, Safety, COBE etc... ).
- Planning and timely execution of activities related to analytical quality assurance.
- Review and release of exhibit and commercial batches as per agreed timelines.
- Review of cGMP (current Good Manufacturing Practices) compliance and adherence to norms.
- Review and approval of documents such as stability study, hold time study and cleaning validation study related protocols & reports.
- Review and approval of method validation, method transfers, method verification related protocols & reports as applicable.
- Review and approval of validation protocols and reports with respect to IQ/OQ/PQ for Facility, Area, Equipment, and Utilities as applicable.
- Review and approval of trend data of stability, water trends and environmental monitoring trend data as applicable.
- Evaluation, review and approval of risk assessments and change controls.
- Participation, review and approval of investigations, corrective actions and preventive actions pertaining to incidents / 00S / OOT.
- Review arid approval of specification and standard test procedures as applicable.
- To perform & participate the Internal and External audits.
- Imparting training to Quality Assurance personnel and new recruits.
- Verification and approval of standard operating procedures as applicable.
- To ensure timely completion of all related notifications as applicable.
- To prepare and review periodical trends of notifications, data presentation to senior management as applicable.
- To ensure adherence and implementation of applicable procedures in respective areas.
- To lead and develop a cohesive team to ensure appropriate capability and delivery.
- To participate and support continuous improvement projects
- To participate and follow safety, health and environmental procedures and practices.
- To carry any other activities assigned by upward reporting staff.
MSc
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