Beschreibung
An international client based here in Solothurn is looking for several Computer System Validation (CSV) Managers to join the team.
The contract will start immediately and go on until the end of the year. Please find a description below:
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 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
- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.)
Requirements:
- 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 or more experience as a Computer System Validation (CSV) Manager
This is an English speaking role based in Solothurn, Switzerland. We are a Swiss agency and are based in Zurich and Neuchatel.
We are not a UK agency recruiting from the UK who have to place you through a payroll operation here in Switzerland. You will go on our books and benefit from our years of experience and personalised high level of service.
We can help you with most of the aspects of living and working here. Please email me your CV if you would like to know more about this great opportunity.