Beschreibung
Task:Planning and implementation of qualification / validation activities and projects of new and existing computer systems according to
Synthes internal and external requirements for all departments within Synthes 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
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- 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 (Must have):
Requirements:
Higher education (Engineer or similar) and background in IT and at least 5 years work experience
Responsility in similar mangement 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
Very good communication-skills!
Minimal language skills:
English & German fluent
Beginn: 07.01.2014
Dauer: 15.08.2014
Branche: Medizin/Healthcare