Computer System Validation (CSV) Managers

COMPUTER VALIDATION MANAGER

MAIN PURPOSE OF ROLE

- Planning and implementation of qualification/validation activitives and projects of new and existing computer systems according to internal and external requirements for all departments within 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, contol and maintenance and of the CSV framework in EMEA
- Definition of the global CSV framework in collabration with the regional CSV responsibles from US and China
- Approving change requests and monitor the necessary activities for the requalication/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.
- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.)

REQUIREMENTS

- Responsibility in similar management position or extended experience as executer required
- Knowledge of national andf international regulations and standards - GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
- We are looking for a minimum of 5 years experience
- English is Required, German is desirable.

Randstad Technologies Ltd is acting as an Employment Business in relation to this vacancy.