Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Senior CSV Engineer (m/w)

Eingestellt von mymotion.de

Gesuchte Skills: Engineer, Support

Projektbeschreibung

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

Projektdetails

  • Einsatzort:

    Deutschland

  • Projektbeginn:

    asap

  • Projektdauer:

    6 MM

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

mymotion.de