For our client, a global leader in the development of animal health products and services, we are looking for a
Senior Third Party Quality Assurance Specialist (Sr. Quality Associate), (m/w/d)
To support third party quality operations at EEM-EMEA and ensure that third party products are produced and released according to Elanco requirements, maintain quality systems which monitor the compliance of distributors.
- To support QA management in any quality related matter
- To perform QA oversight on assigned external suppliers 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 suppliers, contractors, distributors and ensure that relevant quality agreements are current and in place, supplier risk assessments are periodically performed and Product Quality Reviews (PQR) meets 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 EEM-EMEA quality function 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.
EDUCATION & EXPERIENCE
- Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering;
- Experience in quality operations in a GMP environment;
- Excellent command of English and German is a must
- Knowledge and understanding of regulatory requirements;
- Very good knowledge in office tools and SAP (e.g. Word, Excel).
- 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.
Start date: As soon as possible, notice period is also ok
Actual End Date permanent position
Place of work: Basel
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Stefanie Bucheli +41 61 270 80 17.
We are looking forward to getting to know you!