It/ot Quality Specialist

FUJIFILM Biotechnologies

Hillerød, Denmark
**
Computer system validation (csv)
Gxp areas
It and automation qa support
** FUJIFILM Biotechnologies is seeking an IT/OT Quality Specialist to join their QA Digital Technologies team in Hillerød, Denmark. The ideal candidate will have experience in computer system validation within GxP areas and a collaborative mindset to thrive in a dynamic environment. **

Job Summary

  • You will take part in projects implementing and/or upgrading computer systems, lifecycle activities, and contribute to global QA alignment on CSV and lifecycle tasks.
  • Perform QA support to IT and Automation on CSV matters; review and approve system development and life cycle artefacts, validation and change control documentation for computerized systems supporting GxP processes.
  • Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations.

Matching Summary

Match Score: 75

** FUJIFILM Biotechnologies is seeking an IT/OT Quality Specialist to join their QA Digital Technologies team in Hillerød, Denmark. The ideal candidate will have experience in computer system validation within GxP areas and a collaborative mindset to thrive in a dynamic environment. **

Skills & Requirements

Must-have

  • Computer System Validation (CSV)
  • GxP areas
  • IT and Automation QA support
  • Data Integrity
  • Risk-based methodology

Nice-to-have

  • Collaborative mindset
  • High pace environment
  • Continuous development
  • Global alignment tasks

Key Requirements

  • 3-5 years of work experience
  • GxP guidance
  • 21 CFR Part 11
  • Annex 11
  • GAMP5
  • ITIL
  • Speak and write English fluently

Work Rights

Not specified

Tailored Resume

Cover Letter