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CSV Business Analyst

Solothurn  ‐ Vor Ort
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Schlagworte

Beschreibung

For a contract with our client in Solothurn we are looking ASAP for a

CSV Business Analyst

Key Requirements:

  • Work with IT and Computer System Compliance (CSC) partners on remediating computer systems at manufacturing plants
  • Work with and support the Business Owners with the business deliverables for Computer Systems Validation of GXP including not limited to: Requirements Identification and documentation, System Test Scripting, System Test Execution, UAT Test Scripting, Writing of Work Instructions/Procedures
  • Work with IT and CSC in planning of validations of GXP systems.
  • Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
  • Knowledge in technical skills like Technical Writing is requested

    Key Requirements:

  • Higher education (Engineer or similar) and background in Computer System Validation and at least 5 years work experience.
  • Responsibility in similar management 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 11Familiarity with medical device manufacturing plants, SDLC (prefer J&J but can be flex).
  • Minimal language skills: English & German both fluent

    Are you interested in this position? Then we are looking forward to receiving your application.
    • Start
    29.09.2014
    Dauer
    31.12.2014
    Von
    Harvey Nash IT Recruitment Switzerland
    Eingestellt
    07.10.2014
    Projekt-ID:
    786468
    Vertragsart
    Freiberuflich
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