| Location | Breda, Netherlands |
|---|---|
| Business Sector | Biotechnology |
| Contact name | Daria Finikova |
| Contact email | |
| Job ref | 26916 |
| Published | 3 days ago |
As a Specialist QA / Qualified Person, you will play a key role in ensuring that medicinal products released from the site comply with EU GMP and international regulatory standards.
You will work closely with Production, Supply Chain, and Distribution teams, acting as a key quality partner while also contributing to continuous improvement and digital innovation initiatives.
This role offers strong exposure across the business and is ideal for someone looking to develop further as a QP within a leading biotech environment.
Pharmaceutical
Biotechnology
Large multinational biotech
Highly regulated GMP manufacturing environment
Eligible to act as a Qualified Person (QP) under EU Directive 2001/83/EC Article 49
Master’s degree in:
Pharmacy
Life Sciences (e.g. Biology, Chemistry, Pharmaceutical Sciences, Medicine, Veterinary Medicine)
Minimum 2+ years GMP experience in a pharmaceutical environment
Strong understanding of GMP, regulatory requirements, and batch release processes
Experience with deviations, CAPA, and quality systems
Strong analytical and risk-based decision-making skills
Excellent communication and stakeholder management skills
Experience in biotech manufacturing environments
Exposure to digital transformation / continuous improvement projects
Experience supporting regulatory submissions and QP declarations
Experience working in cross-functional/global teams
Perform batch certification for medicinal and investigational products in line with EU and international regulations
Act as QA partner to Production, Warehouse/Distribution, and Supply Chain
Serve as key QA contact for Deviations and CAPAs, ensuring proper investigation and closure
Write, review, and approve SOPs, procedures, and job aids
Review and sign QP declarations and regulatory documentation
Drive and contribute to continuous improvement and digital innovation initiatives
Ensure compliance with corporate, site, and regulatory requirements