Qualified Person (QP)
On-siteBaarle-Nassau, North Brabant, The Netherlands
Baarle-Nassau, North Brabant, The NetherlandsOn-siteFull TimeEnterprise
Full TimeEnterprise
Job Summary
Conduct batch release and review radiopharmaceutical product analysis to ensure compliance with EU Directive 2001/83/EC and Dutch cGMP regulations. Partner with Supply Chain for reliable product supply while managing deviations, CAPAs, and quality complaints to safeguard patient safety. Provide quality oversight for site operations, including validation status, equipment, and personnel training, while writing and approving GMP documentation. Act as Subject Matter Expert during health authority and internal audits, and deputize for the Quality Operations Manager as required.
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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