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Computer System Validation Process Manager

Eingestellt von eCRM Euro Ltd

Gesuchte Skills: Support

Projektbeschreibung

Process owner of the 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 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 
- Development, control and maintenance and of the CSV framework in EMEA 
- Definition of the global CSV framework in collaboration with the regional CSV responsibles 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

Projektdetails

  • Einsatzort:

    Zug, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    1 Year + Extension

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

eCRM Euro Ltd