Qualified Person (QP) – Pharmaceutical Batch Release
novartis · Baarle Nassau
Job description
About the role
The Qualified Person (QP) is responsible for the timely release of radiopharmaceutical products, ensuring product quality and compliance with cGMP, Dutch legislation and EU pharmaceutical regulations.
Key responsibilities
- Review and release batch analysis in accordance with EU Directive 2001/83/EC and national regulations.
- Provide quality oversight for site operations, including validation, equipment qualification and training.
- Investigate and manage deviations, CAPAs, change controls and product quality complaints.
- Act as Subject Matter Expert during health authority inspections and audits.
Required profile
- Master’s degree in a scientific discipline (Pharmacy preferred).
- 3+ years of experience in Quality Assurance or a similar role within the pharmaceutical/biotechnology industry.
- Fluent in English, both written and spoken.
Required skills
- Strong knowledge of GMP and cGMP requirements.
- Familiarity with EU pharmaceutical legislation, especially Directive 2001/83/EC.
- Hands‑on experience with batch release and radiopharmaceutical products.
What we offer
- Competitive base salary EUR 56,100 – 104,300 per year.
- Performance‑based bonus potential.
- Flexible and hybrid working options where possible.
- Minimum 14 weeks paid parental leave.
- Comprehensive benefits including insurance, retirement plans and wellbeing resources.
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Published 8 uur geleden
Expires over 1 maand
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novartis
Baarle Nassau