Senior CSV Engineer (m/w)

DE  ‐ Vor Ort
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Schlagworte

Beschreibung

Aufgaben: * CSV Engineer = Computer System Validation * 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 * Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations * 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.) Qualifikationen: * 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
Start
06.2013
Dauer
6 MM
Von
mymotion.de
Eingestellt
23.06.2013
Projekt-ID:
555816
Vertragsart
Freiberuflich
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