Beschreibung
Task:- Planning and implementation of qualification / validation activities and projects of new and existing computer systems according to internal and external requirements for all departments
- 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
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Performing CSV trainings
Requirements (Must have):
- Responsility in similar management position
- several years experience in CSV
- Knowledge of national and international regulations
- and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
- Experiences with Polarion
- English & German fluent
Beginn: 01.03.2016
Dauer: 31.12.2016
Branche: Medizin/Healthcare