Your new company
At Hays Specialist Recruitment we have an outstanding opportunity for a Qualified Person to join our Biopharmaceutical client in Dublin on an initial contract.
Your new role
1. Qualified Person certification and batch release of clinical supplies
2. Acts as a Responsible Person on a WDA for Pre-Approval Access
3. Support for Health Authority GMP/GDP inspections and audits across the supply chain
4. Advise stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
5. Incorporate global regulatory trends and changes into Supply Chain Quality
6. Site master file maintenance
What you'll need to succeed
7. A degree in science, engineering or related discipline is essential along with 10 years' experience in a role within the biopharmaceutical/pharmaceutical industry.
8. Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorisation
9. Previous experience as a Responsible Person on a WDA is preferred.
10. Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance