<div class="show-more-less-html__markup show-more-less-html__markup--clamp-after-5 relative overflow-hidden"> <p>Roche Diagnostics in Rotkreuz (ZG), the world leader in in-vitro diagnostics, is looking for a team-oriented, inquisitive and independent person with first experience in highly regulated environment</p><p><br/></p><p><strong>Process Management Support (a)</strong></p><p><br/></p><p>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.</p><p><br/></p><p><strong>Your tasks</strong></p><p><br/></p><ul><li>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</li><li>Support translation of multi-level requirements via Requirements Management process</li><li>Conduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representatives</li><li>Ensure all risks and requirements are maintained within a database and streamline approach across projects</li><li>Ensure the delivery of timely and good quality risk and requirements documentation</li><li>Establish and perform Configuration Management in complex development projects</li><li>Support development projects as Verification Manager (Planning, Guiding, Training, Reporting)</li><li>Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments</li><li>Information gathering from respective stakeholders including consolidation of information</li><li>Independent execution of work packages within area of responsibility</li><li>Organize and manage their own time within scope of assigned work packages</li><li>Ensure the delivery of timely and good quality documentation</li></ul><p><br/></p><p><strong>Your qualifications</strong></p><p><br/></p><ul><li>University degree in Life Sciences, Natural Sciences or Engineering</li><li>Good technical understanding of development processes</li><li>First experience in product development in a highly regulated environment is preferred</li><li>Experience in the Diagnostics industry and experience within the GMP regulated environment</li><li>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</li><li>Experience in Process Management (Risk- Requirements- Configuration- and/or Verification Management) or Product Development such as testing is an advantage</li><li>Database experience</li><li>Excellent verbal and written communication skills in English, German is an advantage</li><li>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</li><li>Excellent communication and presentation skills</li></ul><p><br/></p><p><strong>Your application</strong></p><p><br/></p><p>Please apply online. For further information about the position, please contact your Gi Consultant, Mr. Nazim Sagkol (B. Eng.), (+41 76 349 85 07)</p><p><br/></p><p>Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton and Bautech Personal. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 40 locations across Switzerland and over 200 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.</p> </div>