For our customer in Basel, we are looking for a
Tasks & Responsibilities:
* Support the responsible Third Party QA Manager to perform QA oversight on assigned third parties manufacturing products, ensuring that the delivered products comply with Elanco quality standards and legal requirements.
* Review and assess external customer complaints in the global complaint system, including Root Cause Investigation correctness, product impact assessment, trend/recurrence evaluation, and proposed CAPA assessment, within designated timeframes.
* Review and assess Third-Party deviation reports for correctness/completeness, including Root Cause Investigation, assessment of product impact, trending/recurrence evaluation, and suggested CAPA.
* Review batch release documentation provided by third parties to support the Authorized Person for technical release of products for shipment, including material status change in SAP.
* 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 a base for his final review.
* Monitor third party KPI’s to proactively detect and notify QA management of any compliance issues on supplier level that would risk supply of products.
* Support QA management in any quality-related matter.
* Represent the quality function and provide QA support in assigned projects and expert teams.
Must Haves:
* Degree in Pharmaceutical Engineering, Chemistry, Biology, Pharmacy or similar.
* Good knowledge of Office tools (e.g. Word, Excel, SAP).
* Experience in quality operations in the GMP environment and Critical Thinking.
* Experience in customer complaint and deviation handling.
* Experience in packaging operations in the GMP environment.
* Experience in QA systems that support Third Party management.
* Knowledge and understanding of regulatory requirements.
* Working experience within a global organization.
* Fluent in English; German is a plus.
Information:
* End date: 1 year (extension possible).
* Holidays: 25 days.
* On Site/HO: hybrid.
Seniority Level
Associate
Employment Type
Full-time
Job Function
Other
Industries
Chemical Manufacturing
#J-18808-Ljbffr