Beschreibung
An international customer, based in central Switzerland, is looking for several
Qualification and Validation Engineer - Senior
Overall Responsibilities:
Process owner of the EMEA computer system validation (CSV) process. Definition of the global CSV process in collaboration with US and China and global leadership for the CSV process.
Tasks
- Planning and implementation of qualification/validation activities and projects of new and existing computer systems according to the customers 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
Extended Duties:
Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).
Requirements:
- Higher education (Engineer or similar) and background in IT and at least 5 years work experience
- Responsility 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
Duration:
Start: 01.04.2013
End: 31.12.2013
Interested? Then send us your application by clicking on the button/link. Please do not hesitate to call Fabio Guerreiro from Experis, shall you need further information.