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Process management support

Zug
ITech Consult
Inserat online seit: 12 Mai
Beschreibung

Process Management Support - Product Development / Process Management / Verification Manager / Diagnostics industry / GMP / English Background The DCE CH subchapter is part of DSI within the Development Department of Roche Diagnostics in Rotkreuz (Switzerland). The main purpose of our subchapter is the support of development projects and product care activities with development processes like Requirement Management, Product Risk Management, Configuration Management and Defect Management. For this goal our team members are embedded into project teams and product teams, executing such processes by taking the responsibility of authoring the respective documents and ensuring that the processes are followed by the development teams. The Perfect Candidate The typical Roche Diagnostics product consists of a combination of Hardware, Software, Plasticware and Biochemistry. The perfect candidate would have experience in developing/handling all these types of materials and understanding how they come together. Additionally the ideal candidate should be able to navigate in a dynamic project environment, where quite often exceptional situations occur. Efficient process management is not only working according to a checklist, but also understanding the product and project team with its challenges and issues and finding process solutions which keep the compliance and benefit the project. Tasks & Responsibilities * Responsible for process guidance, process optimization and documentation of various development projects (systems and assays) regarding Requirements- and Risk-Management, Configuration Management, Verification and Validation Management, defects management and/or Usability Engineering * Support translation of multi-level requirements via Requirements Management process * Conduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representatives * Ensure all risks and requirements are maintained wi...

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