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Product Quality Manager (PQM)
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Full-time
- POSITION SUMMARY: This role is responsible to plan, co-ordinate, lead and manage the activities of the Operational Quality Section within the North American region, to ensure that all the relevant process raw materials, intermediates and final products are manufactured, packaged, tested, and dispositioned in full compliance with cGMP and regulatory requirements that meet the defined quality standards for the US and Most of World.
- Provides final INDV oversite of formulation, manufacturing, packaging, and inspection records to ensure GMP completeness, accuracy, and legibility.
- Reviews the learnings from all quality issues and failures to decide whether changes are required to the eQMS.Raises deviations as necessary and contributes to investigations, root cause analysis and CAPA identification on a case-to-case basis.
- Drives completion of deviations, ensures CAPA have been implemented and monitored for effectiveness to ensure Indivior has a quality centric continuously improving business.
- Communicates any trends to Indivior senior management as well as CMO governance team routinely.
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