Senior QA IT Specialist - Hybrid, Dundalk

<p><b>Job Description</b></p><p></p><p><span><span>A fantastic opportunity has arisen for a Senior QA IT Specialist within our global Digital and Data Quality (DDQ) team. At our company, we are dedicated to ensuring the integrity and compliance of our manufacturing IT systems throughout the computerized system lifecycle. </span></span><span> </span></p><p></p><p><span><span>Are you ready to make a significant impact on our<span> </span></span><span>cutting-edge</span><span><span> </span>manufacturing facility in Dundalk, Ireland? In this pivotal role, you will ensure<span> </span></span><span>high standards</span><span><span> </span>of IT system reliability, safety, and compliance within our<span> </span></span><span>state-of-the-art</span><span><span> </span>live virus drug substance and drug product manufacturing facility.</span></span><span> </span></p><p></p><p><b><span>Your Key Responsibilities &amp; Impact</span></b><span> </span></p><ul><li><p><span><span>You will collaborate with System, Process, Data, and IT Owners to select computerized systems that support GMP business processes.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Ensure selected technologies meet business needs, tailoring projects to fit complexity and risk.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Provide independent quality approval for critical qualification and validation documentation, ensuring<span> </span></span><span>high standards</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You'll</span><span><span> </span></span><span>maintain</span><span><span> </span>compliance with company standards and regulations throughout the computerized system lifecycle.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Verify that system owners uphold validated status with approved Operating Level Procedures/Plans.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Review processes and documentation to ensure compliance with computerized systems and data integrity.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Support regulatory inspections and audits, resolving nonconformance issues for GMP computerized systems and data integrity.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You'll</span><span><span> </span></span><span>monitor</span><span><span> </span>and communicate system health, compliance, and metrics updates to stakeholders, ensuring effective operation of manufacturing<span> </span></span><span>shopfloor</span><span><span> </span>systems.</span></span><span> </span></p></li></ul><p><b><span>What<span> </span></span><span>We’re</span><span><span> </span>Looking For</span></b><span> </span></p><p><i><span>Required</span></i><span> </span></p><ul><li><p><span><span>You hold a<span> </span></span><span>Bachelor’s</span><span><span> </span>degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences) or equivalent.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Hands-on experience with automated systems in pharmaceutical manufacturing, IT infrastructure, or laboratory operations.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Strong understanding of IT<span> </span></span><span>system</span><span><span> </span></span><span>change</span><span><span> </span>control, data integrity, and regulatory compliance.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You<span> </span></span><span>possess</span><span><span> </span>knowledge of computerized system validation and compliance principles.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Experience implementing quality systems in pharmaceutical, laboratory, or biotechnology environments.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Strong analytical problem-solving skills and the ability to integrate diverse perspectives.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Project management skills, with a sense of urgency and adaptability to changing priorities.</span></span><span> </span></p></li></ul><p><i><span>Preferred</span></i><span> </span></p><ul><li><p><span><span>It’s</span><span><span> </span>a bonus if you have experience in regulatory inspection and audit activities.</span></span><span> </span></p></li></ul><ul><li><p><span><span>An advanced degree in a relevant field is likewise beneficial.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Certification in project management or quality assurance is a nice-to-have.</span></span><span> </span></p></li></ul><p><span> </span></p><p></p><p><b>Required Skills: </b></p>Biopharmaceutical Operations, Change Management, Computer System Validation (CSV), Data Integrity, Deviation Management, GMP Compliance, Manufacturing Quality Control, Quality Assurance (QA), Quality Management Systems (QMS)<p></p><p><b>Preferred Skills: </b></p><p></p><p>Current Employees apply <a href="https://