My duties
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 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

My Qualifications
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

My Benefits
Attractive working environment within a highly motivated team

About Hays

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

My contact at Hays

My contact person

Laura Feig

Contact

E-Mail: [email protected]

Reference number

612397/1