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Your new companyAt 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- Qualified Person certification and batch release of clinical supplies
- Acts as a Responsible Person on a WDA for Pre-Approval Access
- Support for Health Authority GMP/GDP inspections and audits across the supply chain
- Advise stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
- Incorporate global regulatory trends and changes into Supply Chain Quality
- Site master file maintenance
- A degree in science, engineering, or related discipline is essential along with 10 years' experience in a role within the biopharmaceutical/pharmaceutical industry.
- Must be eligible to act as Qualified Person on the Manufacturing/Importation Authorization
- Previous experience as a Responsible Person on a WDA is preferred.
- Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes, and principles of Quality Assurance