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Senior Third Party Quality Assurance Specialist, EEM Basel
Role overview: To support third party quality operations at Turntable Basel 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.
To perform QA oversight on assigned external customers/distributors and third parties manufacturing Elanco products, ensuring, that the delivered products comply with legal requirements and Elanco quality standards.
To act as Authorized Person for release of products for shipment including QA 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 utilize established QA systems for the QA oversight of external customers/distributors 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 represent the quality function within Elanco Basel and to give QA support in assigned projects and expert teams as SME.
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 support QA management in any quality related matter.
Required skills, experience and education:
Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering;
Experience in quality operations in a GMP environment;
Excellent command of English, fluent in German (other languages appreciated);
Drive and a passion to win attitude
Knowledge and understanding of regulatory requirements;
Very good knowledge in office tools and SAP (e.g. Word, Excel).
Preferred skills, experience and education:
Good negotiation and influencing skills,
Result driven and customer focused
Experience in customer complaint handling;
Experience in the negotiation QA contracts;
Experience in QA systems that support Third Party management;
Working experience within a global organization.
Reports to: Head Quality Unit Basel DP Location: Elanco Basel, Switzerland Travel requirements: n.a.
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