IT Validation/Quality Manager (CSV, 21 CFR, SOX, GxP)

Bayern  ‐ Vor Ort
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Beschreibung

RED is currently hiring a IT Validation/Quality Manager on behalf of a Global Key Partner to participate on an ongoing IT implementation programme.

Please find details below:

Role: Project/IT Quality Manager

Location: Close by Munich (Germany) + limited EU travel (Ireland, Czech Republic or Switzerland)

Start: ASAP (no later than 28th August 2017)

Duration/End: 6 months initially + extensions

Capacity: Full time, 5 days per week

Language: English

Details:

Job Responsibilities:

  • Must have worked on validation of SAP systems/applications in the past.
  • Should have experience in use of SAP solution manager and HPQC testing tools
  • Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Quality Management; and Computerised System Validation concept with regards to document management.
  • Support project managers on the application of the project methodology
  • Driving achievements of the Validation/Quality goals by ensuring that the process and standards defined for the project are followed
  • Escalating project quality issues to project team & Program Project Quality Manager.
  • Along with the project manager, prepare and reply to project-related CSV or audits, assessments or inspections where applicable
  • Supporting PM in risk management activities
  • Along with the project manager, participate and document project handover to operations
  • Change management from quality manager role perspective
  • Create/review and approve high level project deliverables (project management and quality management)
  • Record project-originated GxP deviations where applicable
  • Reviewing and managing test deviations from compliance perspective
  • Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable

If you are interested or would like to know more details, please send your CV and availability to (see below) for consideration. All applicants must have a valid EU passport.

Start
ab sofort
Dauer
6 months+
(Verlängerung möglich)
Von
Red - The Global SAP Solutions Provider
Eingestellt
18.08.2017
Projekt-ID:
1400726
Vertragsart
Freiberuflich
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