Qualification & Validation Engineer

Vertragsart:
Vor Ort
Start:
17/11/2014
Dauer:
9 months +
Von:
MSI Recruitment Ltd
Ort:
Schaffhausen
Eingestellt:
29.10.2014
Land:
flag_no Schweiz
Projekt-ID:
798751

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Validation Engineer

A top 10 Pharmaceutical company based in the German region of Switzerland are looking for a Qualification & Validation Engineer in IT/Equipment to join their company on a 9 Month project.

Responsibilities:

  • Transition from laboratory systems to Windows 7 with corresponding re-qualification of the systems.
  • Create/adjust the qualification protocols to Client Standard (URS, IQ, OQ).
  • Coordination of equipment installation with the relevant laboratories specialist and IT team. Implementation and documentation of IQ tests according to specifications.
  • Assistance in the implementation of the OQ tests according to specifications (together with laboratory and external specialists).
  • Creating the qualification reports to Client Standard (IQ, OQ, summary report).
  • Adjusting the master data in SAP-PM database.
  • Create/adjust maintenance requirements.

Requirements:

  • Previous experience of relevant laboratory equipment: Photometer, DSC, cIEF, titration devices, density meters, TOC, particle counter, NIR
  • Science studies or chemistry laboratory with at least 2 years experience in a GMP environment.
  • At least 1 year experience in qualification of equipment in a GMP Environment including 21 CFR Part 11
  • Very good German and good English skills in speaking and writing.
  • Very good understanding of IT