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Senior Manager, GMP Quality
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- Senior Manager GMP Quality
- Reports to : Associate Director, GMP Quality
- The senior manager of GMP Quality will be responsible for interfacing with global contract manufacturing organizations (CMOs) and providing GMP Quality oversight both internally and externally related to the quality management system, deviations, CAPAs, change control, technical transfer activities while ensuring activities are performed according to applicable guidelines and regulations.
- Perform batch disposition through batch record and data review/approval and managing process deviations for timely release.
- Review and/or approve deviations, OOSs, CAPAs, change controls in an efficient manner for adequate and timely closeout of these events for both internal and external GMP and CMC activities.
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