Shape the quality of investigational medicines and ensure seamless clinical trials!
Join our dynamic Clinical Supply Chain Quality team in Dublin and play a vital role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs) for global clinical trials. As a Quality Assurance Specialist, you will be responsible for a range of critical activities, from batch release and maintaining regulatory authorisations to providing QA oversight for packaging, labeling, and logistics.
Your responsibilities will include:
- Compiling and reviewing batch release dossiers for Qualified Person (QP) certification of IMPs.
- Maintaining the site Manufacturing and Importation Authorisation (MIA) and Site Master File.
- Generating and maintaining Product Specification Files (PSF) for IMPs.
- Providing QA support for packaging and labeling operations.
- Supporting the creation and maintenance of Quality Agreements.
- Managing the Quality Assurance aspects of the Use Date Extension process.
- Providing GMP/GDP guidance and training to CSO Logistics (EMEA and Asia).
- Leading and supporting investigations of non-conformances and quality incidents, including root cause analysis and CAPA management.
- Managing supplier and customer qualification processes for the Responsible Person (RP).
- Supporting Health Authority inspections and internal audits.
- Preparing and reviewing procedural documents, change controls, and CAPAs.
- Collaborating with cross-functional teams to ensure GMP and regulatory compliance.
- Championing continuous quality improvement initiatives.
To succeed in this role, you will need:
- A degree in science, engineering, or a related discipline.
- A minimum of 3 years' experience in a Quality Assurance role within the biopharmaceutical/pharmaceutical industry.
- A strong understanding of ICH/GMP, data integrity, regulatory guidelines, clinical supply chain processes, and QA principles.
- The ability to work independently and collaboratively within a matrix team to meet deadlines.
- Excellent communication, presentation, and critical thinking skills.
