Quality Assurance Specialist

Location: Dublin – College Park
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.