Beschreibung
For our client we are currently looking for multiple Computer System Validation (CSV) Managers in Solothurn, Switzerland.
Start date: ASAP
Duration: 9 months + (with option to extend)
Location: Solothurn, Switzerland
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 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, control and maintenance and of the CSV framework in EMEA
- Definition of the global CSV framework in collaboration with the regional CSV responsible for 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
- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and
- infrastructure needs, validation of software, etc.).
Requirements:
- Having worked in a 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
- We are looking for Consultants with approximately 5 years experience, English is a must, German would be an advantage.
Please quote reference number M94448A in the subject of all correspondence.