Kitchen manager in állások, munkák minőségbiztosítás kategóriában

• QC of ICSR related activities to ensure compliance to Customer and regulatory agency requirements.
• Case intake activity for ICSRs related performance during the work.
• Ensure the Quality and TAT targets are defined and met.

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

Investigating and understanding the manufacturing processes and used raw materials, as well as troubleshooting issues and improving process efficiency....

• Develop, modify, and maintain quality evaluation and control systems for materials, in-process parts, and finished products.
• Translate product requirements/specifications into test plans, methods, and fixtures to ensure product reliability.

• Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
• Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy

• Start Date: 16 February 2026
• Latest Possible Start Date: 16 March 2026
• Planned Duration: 12 months
• Extension: Very likely (approved budget)
• Location: Rotkreuz
• Workload: 100%
• Home Office: Yes, less than 50%
• Team Size: 28 people
• Department: Design Control Excellence CH (DSRSPC)

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• Lead and manage the site's full CAPEX portfolio, ensuring prioritization, regulatory compliance and alignment with corporate strategy.
• Lead, coach and develop a team of Project Managers and Controllers, ensuring effective resource planning and high performance.

Execution of consulting projects with a focus on developing market access and dossier strategies, including preparation of corresponding workshops, and participation in oral hearings with relevant authorities...

• Ensure Data Management activities comply with internal standards and regulatory requirements (e.g., ICH-GCP)
• Support the development and testing of (e)CRFs and data review tools
• Contribute to the creation and maintenance of Data Management documentation

• Lead the commercial development of profitable lab testing services
• Lead and develop the lab organization
• Monitoring of the laboratory and all work carried out there, to ensure compliance with relevant internal procedures and regulations

• Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company's research interest.
• Give insights into clinical data sets and evidence for our company's products to internal stakeholders.

Acting as subject matter expert for global Quality applications (e.g. Veeva QualityDocs, Veeva QMS, LIMS and related systems), ensuring they remain compliant, user-centric, and fit for purpose....

• Drive and complete reimbursement applications for the Vibrant product portfolio
• Build and check health economic models that clearly demonstrate product value by using appropriate software tools

• Lead and develop the Product Risk Management team
• Own and continuously improve the risk management process according to ISOwithin our product development framework
• Ensure high-quality risk analyses and maintain consistent, audit-ready risk management documentation

Provide essential guidance to laboratory colleagues on the planning, execution, and conclusion of analytical tests for in-process and intermediate analytics...

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

Project Leadership & Strategy: Act as the technical lead for instrument hardware product care team, driving workpackage planning, implementation and resource allocation with line management...

• Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure documentation and validation of systems according to internal procedures
• Ensure compliance with internal and external regulatory requirements and guidelines
• Maintain the inventory of software applications

• Act as interface to the analytics representative
• Approve corrections in ProNas and create label data
• Prepare projects (special materials for aliquoting, check packing lists, folders, etc.)
• Assist with and execute trainings
• Issue reserve and stability samples
• Order laboratory materials