Our client develops innovative new products for companion animals and horses, to help them having a longer, healthier and happier life. Our client is a worldwide leader in the development of animal health products and their products enrich the lives of animals in over 70 countries. On their behalf, we are looking for a
Senior 3rd Party Quality Assurance Specialist
In this position, you will ensure that third party products are produced and released according to GMP and company internal requirements.
This includes drafting and negotiating Quality Agreements and conducting the Annual Product Quality Reviews (PQR, AQR). The focus will be on Supply Chain/Shipment of pharmaceutical products.
- 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 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 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.
Your negotiation and influencing skills help you to manage external manufacturing sites (some of them don't always respond as quickly as you would wish). Your result driven and customer focused attitude ensure that you meet timelines and quality standards.
Furthermore, you fulfill following requirements:
- Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or similar field
- Experience in Quality Assurance in a GMP environment is a must
- Experience in QA systems that support Third Party management or Supply Chain / Shipment of pharmaceutical products is highly preferred
- Experience in customer complaint handling is highly preferred
- Very good knowledge in office tools and SAP (e.g. Word, Excel)
- Fluency in English
Assignment start: asap
Duration: 1 year (with chance for prolongation)
Workload: 100% (40h/week)
Workplace: Basel (Switzerland)
Please apply online. For further information about the position, please contact: Mrs Stefanie Bucheli (+41 61 270 80 16).