Qualified Person (Dublin - Part-time)
ClinigenDublin, Ireland
Posted August 12, 2025
Part Time
About the Company
Our mission is to accelerate access to medicines for patients in every corner of the globe: Clinical Services, Product Access and Commercialisation, Pharmacovigilance and Regulatory Affairs.
Job Description
Clinigen is a growing global specialty pharmaceutical services business seeking a Qualified Person (QP) for part-time support. The role involves oversight of contract manufacturers, suppliers, and technical due diligence, ensuring compliance with EU GMP and MHRA regulations. The role is crucial for supporting the growth of the business and ensuring product quality.
Requirements
- Eligible to act as a QP under directive 2001/83/EC (preferably permanent provisions)
- Experience in aseptically produced sterile products and potentially lyophilized dosage form
- Experience of QP certification for release of clinical trial materials under directive 2001/20/EC
- Demonstrable business and commercial awareness
- Experience of working independently and as part of a team
- Experience of working across multiple time zones and in global business cultures
- Knowledge of Directive 2001/20/EC and official guidelines
