Beschreibung
CSV Manager
Computer Systems Validation Manager Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc). 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.
At least 5 years experience. English essential German useful.
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