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Endo International Sr Dir, Quality Assurance in Alathur, India

This position responsible to monitor and accountable for Quality assurance operations at site.

  • 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.

Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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