- Region Zug
- Type of contract Temporary full time
- Sector of activity Pharmaceutical / Biotechnology / Chemical
As a preferred supplier for Roche Diagnostics Int Ltd in Rotkreuz, we are looking for an individual as
(contract for one year, with possible extension). The earliest start date is as soon as possible. Home Office is possible, onsite work will be required too.
Description of the mission
- 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 within a database and streamline approach across projects
- Ensure the delivery of timely and good quality risk and requirements documentation
- Establish and perform Configuration Management in complex development projects
- Support development projects as Verification Manager (Planning, Guiding, Training, Reporting)
- Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments.
- Information gathering from respective stakeholders including consolidation of information
- Independent execution of work packages within area of responsibility
- Organize and manage their own time within scope of assigned work packages
- Ensure the delivery of timely and good quality documentation
- University degree in Life Sciences, Natural Sciences or Engineering
- Good technical understanding of development processes
- Excellent verbal and written communication skills in English, and preferably German in addition
- Database experience preferred
- Experience in Process Management (Risk- Requirements- Configuration- and/or Verification Management) or Product Development is a plus
- Experience in the Diagnostics industry and experience within the GMP regulated environment is a plus
- 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.
- 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.
- Excellent communication and presentation skills
- Open minded team-player with an eye for details
Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application.
- Reference INT-028222
- Published on 8 avril 2022
- ConsultantMarijke van Engelenburg