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Final Drug Product Quality Manager
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- Ensure adherence to facility quality systems such as batch record review, product release, change control, exception management, and product annual reviews.
- Work with manufacturing management in cGMP compliance and quality systems.
- Manage investigations, CAPAs, batch record review, product release, change control, requalification and product quality review associated with Final Packaging organization.
- Assure release of product/materials associated with automated device assembly processes and sterilization of medical devices, including Vaporized Hydrogen Peroxide (VHP) sterilization methods.
- Minimum 7 years' experience in a quality operations position in a biotechnology, biologics, or pharmaceutical manufacturing facility.
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