Quality Assurance Specialist

Location: Athlone Ireland
Business Area: Operations Quality
Job Type: Fulltime Grade C Onsite
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 youll 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. Youll work closely with crossfunctional partners and external partners to ensure we deliver safe compliant highquality 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 daytoday 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 youll bring

Essential

• High school education with relevant experience or an entrylevel bachelors degree in Pharmacy Biology Chemistry Engineering or similar
• Experience working with principles of GxP compliance SOPs and Safety Health & Environment requirements
• Experience accomplishing qualityrelated 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
• OnMarket Technical
• Operational Excellence

External:

• Health Authority inspectors
• Vendors and thirdparty partners

Why Alexion

At Alexion you will have the opportunity to grow and develop within a supportive scienceled and qualitydriven environment. Dublin College Park is a thriving dynamic site with modern facilities a collaborative culture and a strong focus on continuous improvement. Youll make a genuine impact on the quality safety and reliability of products reaching patients around the world.

Ready to make a difference

If youre passionate about quality driven by excellence and looking to grow your career within a worldleading biopharmaceutical company wed love to hear from you.

Apply today and help us deliver lifechanging medicines to patients who need them most.