Return to search results

Documentation Specialist

LocationUtrecht , Netherlands
Business SectorBiotechnology
Contact nameCaitlin Girdwood
Contact email
Job ref25618
Published2 days ago

 

My client is a leading vaccine manufacturer with a long-standing history in public health. The company works under strict international biosafety and GMP standards to ensure vaccine security and quality.

This is a high-priority project with firm internal and external deadlines:

  • Internal deadline: December 2025

  • External deadline: February 28, 2026

Details:

  • Contract Type: Freelance/Contract
  • Start Date: ASAP
  • Duration: Initial contract until EOY, extension thereafter
  • Language Requirement: Dutch (mandatory)
  • On vs Off site: mainly on-site presence required 

We are seeking a Documentation Specialist / Quality Engineer to support the Program Manager in rebuilding and improving the GAP IV framework.

Key Responsibilities:

  • Facilitate internal stakeholder meetings regarding the findings and find solutions based on feedback. 

  • Investigate issues, identify gaps, and propose pragmatic solutions.

  • Support documentation improvements across GMP and biosafety requirements.

  • Align documentation and processes with ISO quality standards and containment rules.

  • Contribute to inspection readiness for 2026 deadlines.

Must-Have Requirements:

  • ISO quality management experience (GMP exposure is helpful but ISO mindset is more important). Biosafety mindset is a plus. 

  • Background in QA systems, documentation control, or quality engineering.

  • Skilled in Root Cause Analysis, facilitation, and problem-solving.

  • Pragmatic, solution-oriented approach with ability to work independently.

  • Fluent Dutch (documentation and stakeholder communication are primarily in Dutch).

    Process:

    • Interviews taking place this week.

    • Fast decision expected.