Qualified Person (QP)
On-siteBaarle-Nassau, North Brabant, The Netherlands
Job Summary
Conduct batch release for radiopharmaceutical products, ensuring compliance with EU Directive 2001/83/EC, cGMP, and Dutch legislation. Review and approve batch analysis, Marketing Authorisation, and GMP documentation while managing deviations, CAPAs, change controls, and product quality complaints. Provide quality oversight for site operations, including validation, equipment, and personnel training, and act as Subject Matter Expert during health authority and external audits. Support a strong quality culture through coaching, training on cGMP requirements, and shift or on-call support. Master's degree in a scientific discipline with 3+ years in pharmaceutical QA required; fluent in English. Located in Baarle-Nassau, The Netherlands.
Required Qualifications
- Master's degree in a scientific discipline
- Pharmacy
- 3+ years of experience in a similar role or in a Quality Assurance position within the pharmaceutical or biotechnology industry
- Strong knowledge of GMP requirements and applicable pharmaceutical regulations
- Hands-on and proactive working style, with the ability to take ownership and drive tasks forward
- Demonstrates an agile mindset by setting clear priorities, collaborating openly, and using feedback to drive continuous, step-by-step improvements, reflecting the core elements of Agile culture within the Dutch organization
- Fluent in English, both written and spoken
- Location: Baarle-Nassau, The Netherlands
- Novartis is unable to offer relocation support for this role
Desired Qualifications
- Pharmacy is preferred
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