Vacature - Jouw nieuwe functie
Qualified Person (QP)
For our client a highly specialized pharmaceutical manufacturing environment, we’re looking to recruit a Qualified Person to ensure compliant batch certification and safeguard product quality within a GMP-regulated setting. This position is specifically interesting as you will operate in a critical role directly impacting patient safety while gaining exposure to a niche and fast-paced pharmaceutical domain.
Pharmaceutical
Quality/RA
Breda-Tilburg area - Netherlands
40 uur per week
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Jouw consultant
Over jouw rol
Zo maak jij het verschil
- Perform batch certification and release of pharmaceutical products in compliance with EU Directive 2001/83/EC and applicable regulations
- Ensure timely product release in close collaboration with Supply Chain to maintain continuity
- Provide QA oversight across manufacturing, QC, and operational activities
- Review and approve deviations, CAPAs, change controls, and product quality complaints
- Escalate critical quality issues impacting patient safety or product supply
- Maintain and oversee the GMP Quality Management System, including documentation and validation status
- Act as Subject Matter Expert during regulatory inspections and audits
- Support and strengthen quality culture through coaching and GMP guidance
Wat nodig is
Wat jij mee brengt
- Master’s degree in a scientific discipline
- At least 3 years experience within QA (as Qualified Person) or a similar role in the pharmaceutical or biotech industry
- Strong knowledge of GMP and EU pharmaceutical regulations
- Hands-on, structured, and solution-driven approach
- Experience handling deviations, CAPAs, and quality systems
- Strong communication and stakeholder management skills
- Fluent in English, both written and spoken
Wat wij bieden
Jouw voordelen
- Opportunity to act as Qualified Person within a specialized radiopharmaceutical setting
- High level of responsibility and autonomy in batch certification
- Exposure to complex and time-sensitive manufacturing processes
- Collaborative and quality-focused working culture
- Opportunities for professional and regulatory development
- Competitive salary and benefits package
- Dynamic role with cross-functional engagement
- Direct contribution to patient access to critical medicines
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