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.
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