Computer System Validation (CSV) Engineer

Do you want to be part of the team that supports Sanquin ICT concerning quality and validation and work for a socially involved organization? Do you want to further implement CSV on a daily basis? Then be sure to read on and apply immediately.

17 dagen geleden

Arbeidsvoorwaarden

Standplaats:
Landelijk / geen vaste standplaats
Dienstverband:
Vast contract
Uren per week:
36 - 40 uur
Opleidingsniveau:
HBO
Aantal jaren werkervaring:
5-10 jaar

Functieomschrijving

Sanquin is currently looking for a Computer System Validation (CSV) Engineer for the ICT department. The primary responsibility will be to coordinate risk-based CSV activities in compliance with FDA / GxP. The role includes the validation of new applications or changes, conducting remediation activities to bring the existing computer systems compliant with industry best practices and guidelines. The job also includes performing periodic reviews to confirm the validation status of applications. Part of the role will include improving the CSV policy and procedures based on industry best practices and guidelines. You will participate in all projects with ICT components (Sanquin wide), interact with all the DevOps teams within ICT as well as with most other ICT teams. The three core values for Sanquin ICT are customer-focus, professionalism and enthusiasm.
Responsibilities include but are not limited to:

  • Coordinate the development, implementation, execution and adherence to procedures and methods related to CSV
  • Preparation, review and issuing of CSV documents as they relate to computer systems. Coordinate the approval of the CSV documents
  • Together with the project leader or application manager, coordinate the integration and UAT testing
  • Recommend to QA ICT acceptance of the computer system, as determined from the CSV tasks performed on the system
  • Organize and maintain validation documentation
  • Improving the CSV policy and methodology in consultation with the ICT and divisional QA teams in accordance with applicable Quality/Regulatory requirements and industry best practices
  • Represent CSV in cross-functional team meetings/projects as required
  • Prepare CSV documents for audits conducted on ICT activities, support QA in implementing audit recommendations.

Functie-eisen

  • HBO educational level
  • At least 7+ years of experience in a QA related position
  • Experience within pharmaceutical environments
  • Experience with FDA/GMP regulated industry
  • Working with intensively with QA departments or a strong background of QA knowledge
  • Ability to work independently and in a team setting
  • Capable to lead the validation activities, including working with project leaders, project teams, ICT and divisional QA teams
  • Ability to impact and influence people/areas in matters related to CSV and GxP compliance
  • Excellent communication (oral and written) in Dutch and English
  • The following competencies;
    • Take responsibility and ownership;
    • Pragmatic and showing initiative;
    • Stress resistant
    • Strong communications skills
    • Organizational skills

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