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.
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