QA Specialist

Quality Assurance Specialist Location: Athlone, Ireland Business Area: Operations – Quality Job Type: Full‑time | Grade C | On‑site Worker Type: Employee Scheduled Hours: 37.5 per week Make a meaningful impact by ensuring the highest standards of product quality At 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 do As 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 reviews Performing timely data entry and documentation relating to quality systems Advising on deviations and contributing to batch disposition recommendations Reviewing and approving investigations, ensuring root causes and effective CAPAs are established Leading customer complaint investigations and approving investigation documentation Reviewing and approving documentation within the change management framework Supporting evaluations of validations, qualifications, regulatory documents, periodic reports and product quality reviews Providing day‑to‑day GxP guidance in line with regulatory requirements and internal procedures Leading and contributing to formal and informal GMP training Coordinating regulatory documentation referrals including dossiers, site impact assessments and QP declarations Supporting process improvements, risk assessments, benchmarking and continuous improvement activities Contributing to data analysis and developing insights on quality metrics and KPIs using digital tools This role carries no direct people leadership but requires strong collaboration across multiple functions. What you’ll bring Essential High school education with relevant experience or an entry‑level bachelor’s degree in Pharmacy, Biology, Chemistry, Engineering or similar Experience working with principles of GxP compliance, SOPs and Safety, Health & Environment requirements Experience accomplishing quality‑related processes within a regulated environment Proficiency with digital tools or systems related to QA reporting, documentation or analytics Desirable Additional experience within pharmaceutical manufacturing, biotechnology, GMP auditing or document control Familiarity with digital quality systems Key relationships - You will work closely with: Internal: Process Execution Team External Quality Regulatory Global Quality On‑Market Technical Operational Excellence External: Health Authority inspectors Vendors and third‑party partners Why 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 Posted 07-Apr-2026 Closing Date 18-Apr-2026 Our 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.