We have aQualified Personposition working for aBiologics companyin thewest of Ireland. Reporting to theQuality Manager, the Qualified Person (QP)will be accountable for providing strongQuality Assuranceoversight ofcommercial vaccine products. This role is responsible for quality oversight and batch certification of finished products within the scope of the company's Manufacturing and Importation Authorisation (MIA), as well as for fulfilling all statutory duties of theQualified Personin accordance with applicableEU regulations.Overview of your responsibilities(full job description available on request):Ensure each commercial batch is manufactured, tested, and released in compliance with Irish law, the relevant Marketing Authorisation (MA), EU GMP, and Annex 16 requirementsFulfil the ethical, professional, and legal responsibilities of the Qualified Person in line with EU RegulationsMaintain in-depth knowledge of all GMP manufacturing steps under QP responsibility for batch certificationVerify the end-to-end supply chain and robustness of pharmaceutical quality systems through final batch certification, including materials, packaging, and critical suppliers, using audit and risk-based approachesConfirm all manufacturing, testing, and certification sites comply with the MA and operate in line with approved processesEnsure all required audits of manufacturing and testing sites, including active substance manufacture, are completed and available prior to batch certificationConfirm all post-marketing regulatory commitments related to manufacturing or testing have been fulfilledKnowledge, Skills and Experience Required for the Role:Prior experience as a named Qualified Person (QP) at a licensed facility preferredBackground in sterile manufacturing and/or biotechnology preferredStrong working knowledge of cGMP in manufacturing and testing environmentsClear, accurate technical and compliance-focused writing skillsPeople management or supervisory experience preferredExperience supporting regulatory inspections and internal GMP auditsProven ability to manage stakeholders and escalate issues appropriatelyFor a confidential discussion and more information on the role contactCourtney Russell.