Senior Specialist QA

AstraZeneca GmbH; Dublin; On-site; EUR 52,000 - 68,000; Full time

Job summary

AstraZeneca is seeking a Quality Assurance Specialist to support Dublin College Park site. The role focuses on guiding core QA processes, investigations, and regulatory alignment within a highly regulated environment.

You will work across functions to ensure data accuracy, lead customer and internal quality reviews, and coach junior team members in quality practices and digital tools.

Qualifications

• Experience with quality processes across multiple QA areas.
• Ability to interpret quality and compliance requirements in a regulated environment.
• Experience troubleshooting quality issues and supporting investigations.
• Experience implementing or using modern digital tools for QA reporting, documentation and analysis.

Responsibilities

• Guide execution of core quality processes across QA areas.
• Lead investigations and support CAPAs with robust root cause analysis.
• Provide GxP expertise and align with regulatory expectations.
• Review documentation and ensure timely, accurate quality data entry.
• Coordinate regulatory documentation referrals and change-management activities.
• Support process improvements, risk assessments and benchmarking.

Skills

Quality processes

Investigations

GxP expertise

Documentation & data entry

Digital QA tools

Education

Bachelor’s degree in Science or Engineering

High school education with significant experience

Job description

Quality Assurance Specialist

Location: Dublin – College ParkBusiness Area: Operations – QualityJob Type: Full‑time | Grade D | On‑siteWorker Type: EmployeePeople 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.

Date Posted 11-Aug-2026

Closing Date 24-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.