Provide end-to-end QA oversight for commercial biologics manufacturing at a bulk drug substance facility. Responsibilities include reviewing batch records and technical documentation, approving SOPs and validation materials, overseeing deviations and change controls, supporting inspection readiness, managing raw material release and supplier activities, and tracking quality metrics. The role requires strong GMP and quality systems knowledge, cross-functional influence, and collaboration across Operations, QC, Engineering, Supply Chain, and Qualified Persons.
QA Specialist – 12 Month FTC
Location: College Park, Dublin
Reports To: QA Manager
About the Role
We’re looking for a QA Specialist to join our Bulk Drug Substance (BDS) facility at ADMF, where you’ll provide end‑to‑end quality oversight across manufacturing, testing, documentation, and product disposition. This is a high‑impact role at the heart of our biologics operation — ensuring every batch we produce is safe, compliant, and ready for patients who rely on us.
You’ll be a key partner to Operations, QC, Engineering, Supply Chain and QPs, helping maintain a robust Quality Management System and supporting inspection readiness across the site. If you thrive in a fast‑paced, highly regulated environment and want to make a meaningful difference, this is the place to do it.
What You’ll Do
- Provide quality and cGMP oversight for all commercial manufacturing activities in the BDS facility.
- Review and approve executed and master batch records, including electronic batch record recipes.
- Review and approve technical documentation such as cleaning, process, and method validation.
- Review and approve SOPs, work instructions, technical reports, and protocols.
- Participate in and provide QA oversight for quality risk assessments.
- Support inspection readiness and engage directly with health authority inspectors.
- Oversee key QMS elements including deviations, change control, calibration, and preventive maintenance.
- Author, review, and approve quality procedures.
- Support supplier management activities.
- Review and release raw materials and components for manufacturing.
- Develop, track, and report quality metrics.
What You Bring
- Fluency in written and spoken English.
- Strong communication and presentation skills.
- Ability to work effectively in a complex, international matrix environment.
- Experience in the pharmaceutical or biotech industry.
- Strong leadership presence and the ability to influence cross‑functionally.
- Solid understanding of GMP, quality systems, and regulatory expectations.
Education
- Degree in Pharmacy, Biology, Biotechnology, Engineering, or another relevant scientific discipline.
Play a pivotal role in safeguarding the quality of life‑changing biologic medicines, where your expertise directly protects patients and strengthens a world‑class manufacturing site.
Date Posted
01-Oct-2026Closing Date
14-Oct-2026Our 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.AstraZeneca Dublin, Dublin, IRL Office
College Business & Technology Park, Blanchardstown Rd N, Buzzardstown, Dublin, Dublin, Ireland, D15 R925
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