Senior .net developer állások Németországban (minőségbiztosítás)

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

Select and qualify packaging suppliers to ensure high-quality materials. Collaborate with suppliers to choose optimal packaging for Fresenius Kabi´s products....

• Coordinate alliance management activities and ensure adherence to contractual commitments
• Support (and later) lead contract-related updates, including tracking and initiating required changes
• Contribute to achieving key alliance business objectives

Lead technical investigations for customer complaints and product CAPAs assigned to R&D, evaluate technical issues that occur during daily use of our systems in hospitals and act as key reference within the R&D team...