Process Manager

INTRODUCTION

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 Zug, we are looking for a motivated and reliable (m/f/d)
Process Manager
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 is a plus.
Start Date: Latest Possible Start Date: Planned Duration of Employment: 1 year Extension: very likely with approved budget Workplace: Rotkreuz Workload: 100% Home Office: Yes: less than 50%

ASSIGNMENT DESCRIPTION

• 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.

REQUIRED PROFILE

• 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

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. jida0cb0fca jit0104a jiy26a