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- To oversee the Quality Assurance function of Par Active technologies Pvt.Ltd.
- Act as a plant representative during Regulatory audits, corporate audits to coordinate auditors/inspectors. To manage and ensure all customers (different sites of PAR) and regulatory related queries/observations are responded satisfactorily and in time.
- Implement the effective Quality Management System and ensure the Document control in line with GMP/ GLP. and ensure GMP systems are in line with corporate policies & procedures.
- Co-ordinate with all the departments for better understanding while investigating the product non-conformances, market complaints, deviations/events/OOS etc. and investigate the reasons for the non-conformances and provide the effective corrective and preventive actions.
- Review and approvals of quality related documents including SOPs, formats, SMF, specifications, MOAs, Validation/qualification documents (protocols, reports) and Annual product quality reviews reports. Approve changes that potentially impact intermediate or API quality
- Liaison with different sites of PAR for all Quality related matters.
- Coordinate with Research & Development, Analytical Research & Development, Manufacturing, Engineering and Quality team and provide quality guidance for successful product/method transfers and executions.
- Acts as a member of the site leadership team and engages in business decision-making from a Quality perspective. Participate/conduct QRB, QRM, QMS, Investigation meetings with cross functional teams.
Sr Dir, Quality Assurance - Alathur, India - Endo
