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SalaryAs a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
To support third party quality operations at EEM EMEA and ensure that third party products are produced and released according to Elanco requirements. To operate and maintain quality systems which monitor the compliance of third party manufacturers and products.
Functions, Duties, Tasks:
- To perform QA oversight on assigned external suppliers and third parties manufacturing product for Elanco and ensuring, that the delivered products comply with Elanco quality standards and legal requirements.
- To act as Authorized Person for release of products for shipment including material status change in SAP.
- To review and approve production deviation reports provided by third parties for correctness and completeness including the assessment of suggested CAPA.
- To review and assess external customer complaints in the global Elanco complaint system including the evaluation of the complaint investigation for correctness and an assessment of proposed CAPA within the due time periods.
- To maintain a batch record review qualification status of contract manufacturers.
- To monitor and to drive EEM-EMEA CAPA system.
- To utilize established QA systems for the QA oversight of external suppliers and contractors and ensure that relevant quality agreements are current and in place, supplier risk assessments are periodically performed and Product Quality Reviews (PQR) meet expectations.
- To monitor third party KPI’s to proactively detect and notify to QA management any compliance issue on supplier level that would risk supply of products.
- To review Third Party Product Quality Reviews (PQR) for quality trends on supplier level including the implementation of necessary corrective actions and provide the Third Party QA Manager with a conclusive summary as base for his final review.
- To overview and request timely annual Pharmacovigilance statements for PQRs.
- To support QA management in any quality related matter.
Minimum Qualification (education, experience and/or training, required certifications):
- Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering;
- Min. 5 years of experience in quality operations in the GMP environment;
- Other languages are an asset;
- Knowledge and understanding of regulatory requirements;
- Good knowledge in office tools (e.g. Word, Excel, SAP).
Additional Preferences:
- Working experience within a global organization.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
