CSV Process Owner - Zug, Switzerland

CSV Process Owner - Zug, Switzerland

Requirements:
Higher education (Engineer or similar) and background in IT and at least 5 years work experience
Responsibility in similar management position or extended experience as executer required. Knowledge of national and international regulations
and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11

Overall Responsibilities:
Process owner of the EMEA computer system validation (CSV) process. Definition of the global CSV process in collaboration with US and China and global leadership for the CSV process.

Tasks
- Planning and implementation of qualification/validation activities and projects of new and existing computer systems according to internal and external requirements for all departments across EMEA
- Advisory and support of application owners to build and maintain GMP conform systems
- Support and consulting during projects handling GxP critical computer systems
- Approving specific computer system validation documentation and acting as software quality assurance
- Development, control and maintenance and of the CSV framework in EMEA
- Definition of the global CSV framework in collaboration with the regional CSV responsible from US and China
- Approving change requests and monitor the necessary activities for the requalification/validation after changes, deviations, etc.
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Developing and performing CSV trainings

Extended Duties:
Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).