Senior QA IT Specialist – Project Support, Hybrid, Dundalk

<p><b>Job Description</b></p><p></p><p><span><span>A fantastic opportunity has arisen for a DDQ Senior Specialist (QA IT) for Capital Projects. You will be part of the global Digital and Data Quality (DDQ) team and will ensure 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>How You'll Make a Difference</span></b><span> </span></p><ul><li><p><span><span>You'll</span><span><span> </span>collaborate with various system and process owners to select computerized systems supporting GMP business processes.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Ensure selected technologies meet business needs and tailor projects appropriately for complexity and risk.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Provide independent quality approval for key qualification and validation documentation.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You'll</span><span><span> </span>ensure compliance with company standards and regulations throughout the computerized system lifecycle.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Monitor that site and above-site system owners<span> </span></span><span>maintain</span><span><span> </span>validated status through approved procedures.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You'll</span><span><span> </span>review processes and documentation to ensure effective compliance activities for 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.</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 and compliance metrics to stakeholders, ensuring effective operation of manufacturing systems.</span></span><span> </span></p></li></ul><p></p><p><b><span>What You Bring to the Team</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 or have equivalent experience.</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>You have a strong understanding of IT system change control, data integrity, and regulatory compliance.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Knowledge of computerized system validation and compliance principles.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Adept at implementing quality systems in pharmaceutical, laboratory, or biotechnology environments.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Strong analytical and problem-solving skills that enhance team goals.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Ability to integrate diverse perspectives to bolster team success.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Project management skills<span> </span></span><span>demonstrated</span><span><span> </span>by delivering quality results and adaptability to changing priorities.</span></span><span> </span></p></li></ul><p><span> </span></p><p></p><p><b>Required Skills: </b></p>Capital Projects, Change Management, Communication, Computer System Validation (CSV), Data Integrity, Deviation Management, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Project Management, Quality Assurance (QA), Quality Management Systems (QMS), Strategic Planning<p></p><p><b>Preferred Skills: </b></p><p></p><p>Current Employees apply <a href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p><p>Current Contingent Workers apply <a href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p><p><b>Secondary</b><b> Language(s) Job Description:</b></p><p></p><p></p><p>We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.</p><p></p><p>As an equal opportunit