QA Specialist

Quality Assurance SpecialistLocation: Athlone, IrelandBusiness Area: Operations – QualityJob Type: Full‑time | Grade C | On‑siteWorker Type: EmployeeScheduled Hours: 37.5 per weekMake a meaningful impact by ensuring the highest standards of product qualityAt AstraZeneca, we are committed to delivering medicines that transform patients’ lives. Ensuring consistent, reliable product quality is central to this mission. Our Dublin College Park site is a key part of our global supply network, and we are now seeking a Quality Assurance Specialist to support internal and external quality processes across our site.This is an exciting opportunity for someone early in their QA career or with foundational experience in GxP environments who is eager to grow, influence quality decisions, and contribute to continuous improvement initiatives.What you’ll doAs a Quality Assurance Specialist, you will complete core quality processes, support investigations, contribute to compliance activities, and ensure quality decisions are made with accuracy and clarity. You’ll work closely with cross‑functional partners and external partners to ensure we deliver safe, compliant, high‑quality products.Your responsibilities will include:Completing core internal and external quality processes such as deviation management, complaint management, supplier quality and product quality reviewsPerforming timely data entry and documentation relating to quality systemsAdvising on deviations and contributing to batch disposition recommendationsReviewing and approving investigations, ensuring root causes and effective CAPAs are establishedLeading customer complaint investigations and approving investigation documentationReviewing and approving documentation within the change management frameworkSupporting evaluations of validations, qualifications, regulatory documents, periodic reports and product quality reviewsProviding day‑to‑day GxP guidance in line with regulatory requirements and internal proceduresLeading and contributing to formal and informal GMP trainingCoordinating regulatory documentation referrals including dossiers, site impact assessments and QP declarationsSupporting process improvements, risk assessments, benchmarking and continuous improvement activitiesContributing to data analysis and developing insights on quality metrics and KPIs using digital toolsThis role carries no direct people leadership but requires strong collaboration across multiple functions.What you’ll bringEssentialHigh school education with relevant experience or an entry‑level bachelor’s degree in Pharmacy, Biology, Chemistry, Engineering or similarExperience working with principles of GxP compliance, SOPs and Safety, Health & Environment requirementsExperience accomplishing quality‑related processes within a regulated environmentProficiency with digital tools or systems related to QA reporting, documentation or analyticsDesirableAdditional experience within pharmaceutical manufacturing, biotechnology, GMP auditing or document controlFamiliarity with digital quality systemsKey relationships - You will work closely with:Internal:Process Execution TeamExternal QualityRegulatoryGlobal QualityOn‑Market TechnicalOperational ExcellenceExternal:Health Authority inspectorsVendors and third‑party partnersWhy Alexion?At Alexion, you will have the opportunity to grow and develop within a supportive, science‑led and quality‑driven environment. Dublin College Park is a thriving, dynamic site with modern facilities, a collaborative culture and a strong focus on continuous improvement. You’ll make a genuine impact on the quality, safety and reliability of products reaching patients around the world.Ready to make a difference?If you're passionate about quality, driven by excellence and looking to grow your career within a world‑leading biopharmaceutical company, we’d love to hear from you.Apply today and help us deliver life‑changing medicines to patients who need them <most.Date> Posted12-Aug-2026Closing Date25-Aug-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.