Senior Specialist QA

Quality Assurance Specialist Location: Athlone, Ireland Business Area: Operations – Quality Job Type: Full‑time | Grade D | On‑site Worker Type: Employee People Management: None Be part of a team that safeguards product quality and patient trust At Alexion, quality is at the heart of everything we do. Our medicines reach patients worldwide, and our Quality teams ensure that every product meets the highest standards of safety, compliance and performance. We are now seeking a Quality Assurance Specialist to support internal and external quality processes across our Dublin College Park site. This is an excellent opportunity for an experienced quality professional looking to broaden their impact, guide early‑career colleagues, and shape best practices in a highly regulated environment. What you’ll do As a Quality Assurance Specialist, you will guide execution of core quality processes, lead investigations, provide GxP expertise, and support continuous improvement initiatives. You’ll operate collaboratively across functions, helping ensure that quality decisions are made accurately, responsibly, and in alignment with global standards. Your responsibilities will include: Guiding the execution of key internal and external quality processes including deviation management, complaints, supplier quality and product quality reviews Ensuring timely and accurate entry of quality data and documentation Reviewing and approving investigations to confirm robust root cause analysis and effective CAPAs, and monitoring implementation Leading customer complaint investigations and approving reports Conducting and guiding reviews/approvals of documentation across change management, validations, qualifications, PQRs, regulatory submissions and related quality records Providing expert GxP guidance in alignment with regulatory expectations and internal policies Leading coordination of regulatory documentation referrals (e.g., dossiers, impact assessments, annual reports, QP declarations) Supporting and contributing to process improvements, risk assessments, and benchmarking activities Analysing quality data and producing insights on metrics and KPIs using digital tools Supporting planning and delivery of site‑wide quality training Guiding early‑career team members on quality processes, digital tools, documentation and compliance requirements This role requires no direct people management but does involve informal leadership and coaching. What you’ll bring Essential High school education with significant experience or a bachelor’s degree in Science or Engineering (e.g., Pharmacy, Biology, Chemistry) with some relevant experience Experience working with quality processes across multiple QA areas Ability to interpret quality and compliance requirements and guide others in a regulated environment Experience troubleshooting quality issues and supporting investigations Experience implementing or using modern digital tools for QA reporting, documentation and analysis Desirable Experience with pharmaceutical manufacturing, audits, QMS systems or regulated industry inspections Familiarity with digital transformation or automation in quality environments Key relationships You will collaborate closely across functions to resolve issues and drive quality excellence. Internal: Process Execution Team External Quality Regulatory Regional & Global Quality peers On‑Market Technical Operational Excellence External: Health Authority inspectors Vendors and third‑party providers Why AstraZeneca? At AstraZeneca, you’ll play a critical role in ensuring the medicines we deliver are safe, compliant and consistently high quality. Dublin College Park offers modern facilities, cross‑functional collaboration, and opportunities to grow within a global organisation committed to scientific excellence and operational integrity. Ready to make an impact? If you are passionate about quality, motivated by continuous improvement, and ready to influence best practices in a world‑leading biopharmaceutical environment, we encourage you to apply. Join us and help ensure every medicine we deliver meets the highest standards of quality and care. 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.