Senior QA Specialist

Job title: Senior QA Specialist

Company: Morgan McKinley


Job description: 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.

Expected salary:

Location: Dublin

Job date: Sun, 11 May 2025 04:50:07 GMT

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