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Quality Associate - External Manufacturing NA
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- We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise.
- This position is accountable for Quality oversight and lifecycle management of assigned Elanco finished drug products; API; contract manufacturing organizations (CMO's) and suppliers ensuring that Elanco products meet all legal and internal requirements.
- This may include but not limited to the following: parenteral, solid oral dose, non-sterile liquid, premix, API, and EPA/parasiticide products.
- Manage and support positive CMOs / Suppliers selection and on-boarding of CMO's / Suppliers with assurance of compliance with the regulatory, cGMP requirements and the Elanco Quality Manual / Directives
- Partner with technical services & manufacturing operations to assure that CMO deviations are compliant, root cause and CAPA plans are appropriate and implemented in a timely manner.
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