Qualified Person - 12-months - IrelandOne of the top 10 best companies to work in Ireland is looking for a Qualified Person for their large-scale new facility in Ireland. Is this you?An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What You'll DoReview and approve QA/QP procedures, training materials, and Quality Agreements.Support start-up activities, including Manufacturer/Importation Authorisation submissions and knowledge transfer.Perform QP release of Investigational Medicinal Products (IMPs) in line with regulatory requirements.Provide guidance during Health Authority GMP/GDP inspections and audits.Advise stakeholders on quality issue management and process improvements.Maintain Site Master File and oversee Manufacturer/Importation Authorisation updates.Ensure rapid communication of significant quality issues to senior management.Review and approve procedural documents and participate in cross-functional teams.Influence external regulatory environment through interactions with authorities and industry groups.Identify risk areas and contribute to global audit planning.Supervise QA personnel and champion continuous improvement initiatives.What You'll NeedDegree in science, engineering, or related discipline.Extensive experience in biopharmaceutical/pharmaceutical industry quality roles.Eligibility to act as EU Qualified Person under Manufacturing/Importation Authorisation.Experience with QP release of IMPs (preferred) and Responsible Person on WDA (desirable).Strong knowledge of ICH/GMP, data integrity, regulatory guidelines, and clinical supply chain processes.Proven leadership and influence management skills in a global matrix environment.Excellent communication and stakeholder engagement skills.Commitment to fostering a culture of continuous improvement and compliance.*If this role is of interest, please apply now*