Quality and Change Coordinator | Quality & Change Koordinator * Roche Mannheim

Job Summary

This role offers an opportunity to join Roche Diagnostics GmbH in Mannheim, focusing on critical quality assurance and risk management within the regulated pharmaceutical environment. The Quality and Change Coordinator will primarily support packaging material experts by revising the risk management structure for reagent containers. Key responsibilities include preparing and moderating workshops with various interfaces to create detailed Failure Mode and Effects Analyses (FMEAs), and ensuring the standardization and maintenance of these FMEAs across the entire product lifecycle. Additionally, the coordinator will assist in drafting essential quality requirement documents, such such as test instructions and test plans. Successful candidates must hold a degree in Natural Sciences or Engineering and bring substantial professional experience, particularly in quality pre-planning within a regulated context. Expertise in complex plastic processing methods, like injection molding and extrusion blow molding, is a crucial requirement for this temporary position.