QA Specialist

Alexion Pharmaceuticals, Inc.; Athlone; On-site; EUR 52,000 - 70,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in Athlone, Ireland is seeking a Quality Assurance Specialist to support internal and external quality processes and ensure product quality across the site.

This role suits someone early in QA or with foundational GxP experience who wants to grow within a regulated manufacturing environment. You will partner with cross-functional teams, perform deviation handling, investigations and batch disposition activities, and contribute to continuous improvement initiatives

Qualifications

• Experience with GxP principles, SOPs and SH&E requirements.
• Experience delivering quality-related processes in a regulated environment.
• Proficiency with QA reporting, documentation or analytics tools.

Responsibilities

• Complete core internal and external QA processes: deviation management, complaint management, supplier quality, product quality reviews.
• Perform timely data entry and documentation for quality systems.
• Advise on deviations and contribute to batch disposition recommendations.
• Review and approve investigations, ensuring root causes and CAPAs are established.
• Lead customer complaint investigations and approve investigation documentation.
• Review/approve documentation within change management framework.
• Support evaluations of validations, qualifications, regulatory docs, periodic reports and PQRs.
• Provide day-to-day GxP guidance per regulations and internal procedures.
• Lead and contribute to GMP training (formal and informal).
• Coordinate regulatory documentation referrals including dossiers and QP declarations.
• Support process improvements, risk assessments, benchmarking and CI activities.
• Contribute to data analysis and KPI insights using digital tools.

Skills

GxP compliance

SOPs

Safety Health & Environment

QA reporting & analytics

Education

Bachelor-level degree or higher (Pharmacy/Biology/Chemistry/Engineering)

Tools

QA software/systems

Job description

Quality Assurance Specialist

Location: Athlone, IrelandBusiness Area: Operations - QualityJob Type: Full-time | Grade C | On-siteWorker Type: EmployeeScheduled 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.

Date Posted

12-Aug-2026

Closing Date

25-Aug-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.