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Qualified Person (QP)
hays-gcj-v4-pd-onlineDublin North30+ days ago
Job descriptionA 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 Authorisation 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
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
- 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
What you'll need to succeed
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Qualified Qualified • Dublin North