Consultant eCompliance

Basel-Stadt  ‐ Vor Ort
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Schlagworte

Beschreibung

Harvey Nash is looking for a Consultant eCompliance for a 6 month project in Switzerland.

The role is about supporting QA e-Compliance Managers to ensure that all aspects of global and local Computerized Systems comply with GxP regulatory requirements and the related NV&D Quality Manual.

You are responsible for

  • Ensuring that all GxP Computerized Systems comply with the requirements of the NV&D Corporate Quality Manual and meet all relevant GxP regulatory requirements throughout the systems life cycle.
  • Ensuring that Data Integrity is maintained throughout the business process
  • Ensuring that programming and validation procedures comply to the requirements of the NV&D Corporate Quality Manual.
  • Reviewing, evaluation, and approval of Computerized System related quality concepts, plans and documents of divisional and local projects and applications
  • Overseeing QA operations for computerized systems validations and change control
  • Reviewing/approving validation deliverables for global computerized systems in the QA role

Requirements

  • Graduate in Pharmacy, natural sciences or information technology or several years of equivalent experience in pharmaceutical or related industry
  • Experience in GxP regulated Pharmaceutical Industry (eg in Quality Assurance), IT departments, Quality Management Departments or equivalent Consultant positions with excellent knowledge of computerized system validation aspects and 21 CFR Part 11/EU Annex 11 requirements
  • Good experience with Quality Management and Computerized Systems Validation aspects of application implementations and operations (eg Clinical Data Management Systems, ERP/SAP, DMS, LIMS) in the regulated Pharmaceutical Industry.
  • Knowledge in scientific and clinical data management and statistical programming is an advantage
  • Local language, English fluent in speaking/writing

    Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)

  • Start
    24/03/14
    Dauer
    24/09/14
    Von
    Harvey Nash IT Recruitment Switzerland
    Eingestellt
    20.03.2014
    Projekt-ID:
    682077
    Vertragsart
    Freiberuflich
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