[Immediate Start] Quality Audit Specialist

ROLE CAN BE BASED FROM ATHLONE, CORK OR DUBLIN OFFICES

Overview

Introduction to role

Are you ready to make a difference in the world of rare diseases? As a Quality Audit Specialist, you’ll be at the forefront of ensuring excellence within AstraZeneca's Alexion Rare Disease Unit. Your role will involve managing the entire audit and inspection process, from preparation to closure, while implementing best practices and educating employees on audit management systems. Join us in our mission to deliver quality assurance activities that support audits and health authority inspections.

Responsibilities

- Deliver quality assurance activities at Alexion's GQA hub to support audits and inspections.
- Support key stakeholders during audit/inspection preparation and management.
- Develop and communicate audit schedules/plans.
- Create audit agendas by identifying risks/issues and engaging stakeholders.
- Review and issue audit reports.
- Enter report/responses into the Quality Management system.
- Review audit actions from receipt to closure.
- Oversee outsourced activities from assignment to delivery.
- Lead audit consultancy communications for audit program management.
- Work independently and as part of a team.
- Partner with Alexion stakeholders to collect feedback for effective audit function operation.
- Act as a quality point of contact for audit/inspection queries.
- Participate in continuous compliance improvement projects.
- Review and approve SOPs and procedural documentation.
- Act as SME/Quality contact on key Quality system records.
- Support/lead audits when required.

Essential Skills/Experience

- Bachelor's Degree in physical/life science or pharmacy; Advanced degree preferable
- Minimum of 3 years’ experience in a GxP Quality Assurance or Compliance Management related role, with Quality Management Systems knowledge
- Demonstrable communication and project management skills; experience working in cross-functional teams
- Strong Business Partner with a focus on collaboration and delivering results
- Knowledge of applicable international GXP regulations and standards (e.g., GMP, GDP etc.)
- Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written
- Experience with Quality Systems/tools (e.g. Microsoft office, ECMS, EQV, SmartSheet) an advantage

Desirable Qualifications

- Exposure to audits (internal, supplier or corporate) or inspectorates (e.g. HPRA, FDA, NSAI) is an advantage
- Exposure to supplier quality management

Why AstraZeneca?

At AstraZeneca's Alexion Rare Disease Unit, we are driven by our passion to innovate and create meaningful value. Our unique culture combines the entrepreneurial spirit of a leading biotech with the resources of a global biopharma. We are committed to making a difference for patients living with rare diseases by fostering a diverse and inclusive environment where ideas flourish. Join us in our mission to change lives for the better, every day.

Ready to embark on this exciting journey?

Apply now and be part of a team that truly makes an impact

Date Posted 25-Sep-2025

Closing Date 08-Oct-2025

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.

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