Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.
For our client Roche Diagnostics in Rotkreuz, we are looking for a motivated and reliable (m / f / d)
Engineer / Process Supporter 100%
AUFGABENBESCHREIBUNG :
Responsible for process guidance, process optimization and documentation of various development projects (system and assay) regarding Requirements- and Risk-Management, Configuration Management and / or Verification & Validation Management
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 own time within scope of assigned work packages
Ensure the delivery of timely and good quality documentation
ERFORDERLICHES PROFIL :
University degree in Life Sciences, Natural Sciences or Engineering
First experience and good technical understanding of product development processes within a highly regulated environment
Database experience preferred
Experience in Process Management (Risk-, Requirements-, Configuration-, Defect and / or Verification Management) 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 verbal and written communication skills in English, and preferably German in addition
Excellent communication and presentation skills / Open minded team-player
Planned duration : 1 year
Extension : possible
Are you interested and would you like to seize this opportunity? Then we should definitely get to know each other! Simply click on "Apply now" and we look forward to receiving your complete application documents.
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