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CSV Specialist

  • Location:

    Geleen, Netherlands

  • Contact:

    Elisa Antonia Miranda Vásquez

  • Job type:

    Temp to Perm

  • Contact phone:

    +31 (0)20 406 97 50

  • Industry:

    Biotechnology, Materials Science

  • Contact email:

    elisa_miranda@oxfordcorp.com

Do you have experience overseeing computerized system validation (CSV), and would you like to work in an international inspiring environment for a worldly renowned top employer?

Job Description

The CSV Specialist reviews and approves documentation and oversees computerized system validation deliverables. You will review and approve the computerized system validation documents and procedures associated with computerized system operation, cleaning and maintenance, design and configuration specifications, Electronic Records and Electronic Signatures (ERES) and Data Integrity Risk Assessments (DIRA). And provide computerized system and application support and conduct administration of GxP computerized systems.

Working partially remote is possible!

Responsibilities:

  • Overseeing computerized system validation (CSV)
  • Review and approve computerized systems URSs
  • Review and approve risk assessments associated with computerized systems
  • Review and approve design and configuration specifications
  • Review and approve server installation plans and qualification
  • Review and approve computerized systems validation test scripts and validation reports
  • Review and approve Electronic Records and Electronic Signatures (ERES) and Data Integrity Risk Assessments (DIRA)

Requirements

  • Bachelor degree in IT/Biology/Biomedicine
  • Experienced with Quality Management and GxP Regulations
  • Knowledge of validation methodologies
  • Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP manufacturing processes

Benefits

  • Employment type: Direct employer
  • Length of assignment: 1 year
  • Salary range: €3000 - €5000+
  • Extras: Good secondary benefits
  • Region: Limburg (NL)
  • Vacancy number: 19732

IMPORTANT NOTE: Unlimited EU working permit is required. Please do not apply if you do not have a working permit to live and work in the Netherlands. If you do not have an unlimited permit, your application will not be processed.