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Senior Specialist, External Manufacturing Quality
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- Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry.
- Reporting directly to the Senior Manager of Quality, this position collaborates closely with External Manufacturing Organizations (EMO), spanning pharmaceuticals, medical devices/combination products, consumer products/OTC, and biologics sectors, ensuring adherence to cGMP regulations and Bausch Health requirements.
- This position will work directly with External Manufacturing Organizations (EMO) involving Pharmaceutical, Medical devices/Combination products, Consumer products /OTC and Biologics to ensure drug products/ Biologics are manufactured as per cGMP regulations and Bausch Health requirements.
- Coordinates and leads EMQA personnel through the Compliance Wire, Remarque (TrackWise) system which includes but not limited to Quality Events, Management of Change, Supplier Quality Management, Audits and CAPA workflows.
- Medical Devices and/or pharmaceutical manufacturing experience is required.
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