Beschreibung
Process owner of the 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 Synthes internal and external requirements for all departments within Synthes 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 responsibles 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