Computer System Validation (CSV) Specialist NL
Hybrid
About the job
QbD Group is seeking a Computer System Validation (CSV) Specialist to join their team in Breda. In this role, you will own validation activities for GxP systems and apply GAMP5 guidelines with a risk-based approach. You will collaborate with QA, IT, engineering, and operations to ensure compliance and data integrity.
What you will do
- Own validation activities for GxP systems
- Apply GAMP5 guidelines with risk-based approach
- Write and review validation documents
- Champion data integrity using ALCOA+ principles
- Collaborate with QA, IT, engineering, and operations
- Execute tests and support audits
What you bring
- Bachelor's or Master's degree in scientific or engineering discipline
- Hands-on experience in life sciences or software-driven projects
- Familiarity with IT systems and Manufacturing Execution Systems (MES)
- Understanding of GAMP 5, 21 CFR Part 11, and Eudralex Annex 11
- Detail-oriented and analytical mindset
- Team player with practical project management approach
What you get
- Impactful work in life sciences
- Community of experts with mentoring
- Meaningful career growth
- Competitive compensation package
About QbD Group
QbD Group is a company focused on quality by design in the life sciences sector.
Summary by Personeel.com. The full job description and the application form are on QbD Group's website (careers.qbdgroup.com); Apply takes you straight there.
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