Beschreibung
Junior Process Management Support - Process Management (Risk- Requirements, Configuration, Verification Management), EN, DERole:
For our client in the Pharma industry based in Rotkreuz we are looking for a Junior Process Management Support.
Process and Support is part of the Global Molecular Diagnostics (RMD) Development organization with two teams which are located in Pleasanton, USA, and Rotkreuz, CH. Both teams are focused on supporting and managing the processes and procedures for RMD Development, with multiple core competencies, functions, tasks and interactions.
The Process Management Team provides support to the RMD 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.
Areas of responsibility:
- Ensure the delivery of timely and good quality documentation
- 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
Professional and technical requirements:
- University degree in Life Sciences, Natural Sciences or Engineering
- First experience in Process Management (Risk- Requirements- Configuration- and/or
Verification Management) desired
- First experience in the Diagnostics industry desired
- Good analytical thinking, a structured, reliable working manner, ability to prioritize, plan and
manage multiple tasks and to instil 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
- Excellent communication skills in English, and preferably German in addition
- Open minded team-player
- Database experience preferred
Reference no: 919818 AD
Role: Junior Process Management Support
Industry: Pharmaceutical industry
Workload: 100%
Location: Rotkreuz, Switzerland
Start date: 04.01.2021
Duration: 31.12.2021, with possible extension
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.