Location | Utrecht , Netherlands |
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Business Sector | Biotechnology |
Contact name | Caitlin Girdwood |
Contact email | |
Job ref | 25618 |
Published | 2 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:
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.