Beschreibung
CSV Managers & Senior Consultants
Long Term Contract
Solothurn, Switzerland
Salary: Negotiable
Our client is seeking experienced CSV Professionals to join their team on site in Solothurn assisting with planning and implementation of validation projects they are currently undertaking
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:
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
Our client is looking for Consultants with approximately 5 years experience, English is a must, German would be an advantage.
Please email.