Process Management Supporter
(m/f/d)
Freelance/temporary employment for a project Zug Start date: asap Reference number: 873287/1
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Responsibilities
1. 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
2. Support translation of multi-level requirements via Requirements Management process
3. Conduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representatives
4. Ensure all risks and requirements are maintained within a database and streamline approach across projects and ensure the delivery of timely and good quality risk and requirements documentation
5. Establish and perform Configuration Management in complex development projects
6. Support development projects as Verification Manager (Planning, Guiding, Training, Reporting)
7. Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments
8. Information gathering from respective stakeholders including consolidation of information
9. Independent execution of work packages within area of responsibility
10. Organize and manage their own time within scope of assigned work packages
Profile
11. University degree in Life Sciences, Natural Sciences or Engineering
12. Good technical understanding of development processes
13. Excellent verbal and written communication skills in English as well as excellent presentation skills
14. Database experience
15. First experience in product development in a highly regulated environment is preferred (n2H)
16. Good analytical thinking, a structured, reliable working manner, ability to prioritize, plan and manage multiple tasks and to instill a sense of urgency in teams
17. Ability to lead by influence, demonstrated effectiveness, drive decisions and account for results; ability to resolve conflicts and adapt to change, effective to drive results and achieve project goals
18. Open minded team-player with an eye for details
19. Advantageous: Experience in the Diagnostics industry and experience within the GMP regulated environment
20. Advantageous: Experience in Process Management (Risk- Requirements- Configuration- and/or Verification Management) or Product Development such as testing
Benefits
21. Extension very likely (intention for extension)
22. Fascinating, innovative environment in an international atmosphere