Beschreibung
Process Management Support (f/m/d)- Risk- Requirements- Configuration /Verification Management / HW/SW Development / Diagnostics industry / English and GermanProject:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Process Management Support.
Background:
This position as a Process Manager belongs to the Process Management Team as part of the Diagnostics Standard and Interoperability (DSI) department within the Roche Diagnostics Solution (RDS) development organization. Whereas DSI and RDS are globally organized, the main focus for this position will consist of local activities at the Roche Rotkreuz site. A Process Manager provides support to the Development Teams (Assay, Software, Instrument, and System Development) regarding Requirements and Risk Management, Configuration Management, Verification and Validation Management, and Usability Engineering. This requires close interaction with several internal functions in order to gather all necessary information needed to ensure high quality documentation.
The perfect candidate has an university degree in an engineering or life sciences related field and has experience in process management: Risk- Requirements- Configuration- and Verification Management. First experience in hardware AND software development would be a big plus. Experience in the diagnostics industry is of advantage. The hiring manager will consider junior, professional and senior candidates for this position.
Tasks & Responsibilities:
- Responsible for process guidance, process optimization and documentation of various development projects (system and assay) regarding Requirements- and Risk-Management, Configuration Management, Verification and Validation 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.
- Min. first experience in Process Management(Risk- Requirements- Configuration- and/or Verification Management).
- First experience in hardware AND software development is of advantage.
- Experience in the Diagnostics industry desired.
- Excellent verbal and written communication skills in English , and preferably German in addition
- 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
- Database experience preferred
Reference No.: 922166SDA
Role:Process Management Support (f/m/d) Industry:Pharma Workplace:Rotkreuz Workload:80-100% Start: Duration:12++ Deadline :