Process Manager

Vor 7 Tagen

Zug, Schweiz ITech Consult AG Vollzeit

Process Manager (m/f/d): Product Development/ GMP / Process Management / highly regulated environment / Life Sciences or Natural Sciences English Project: For our client based in Rotkreuz, we are looking for a highly qualified Process Manager. Background: The Department Design Control Excellence CH is looking for a process manager with a good understanding of IVD product development processes. The process manager is responsible for process guidance, process optimization and documentation of various development projects. The Perfect Candidate has a university degree in Life Sciences, Natural Sciences or Engineering as well as first experience and good technical understanding of product development processes within a highly regulated environment (working experience or internship). Database experience and experience in Process Management is of advantage. Experience in the Diagnostics industry and experience within the GMP regulated environment isplus. 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 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 Must Haves: * 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 such as testing is a plus * First experience in product development in a highly regulated environment is preferred (n2H) * 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

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