QA Specialist (Extended Days)

Descrizione del lavoro:

QA Specialist (Extended Days)
Shift Pattern: 2 x day shifts (7am-7pm), 2 x late shifts (12pm-12am), followed by 4 days off
Location: College Park, Dublin

About the Role
We're looking for a QA Specialist to support our Bulk Drug Substance (BDS) facility at ADMF, a key role responsible for ensuring the highest standards of GMP compliance across manufacturing, testing, documentation, and product disposition. You'll be central to maintaining a robust Quality Management System, supporting inspection readiness, and partnering closely with Operations, QC, Engineering, Supply Chain and QPs to ensure uninterrupted patient supply.

This is an opportunity to make a meaningful impact in a fast-paced biologics environment where quality truly matters.

What You'll Do
* Provide quality and cGMP oversight for all commercial manufacturing activities in the BDS facility.
* Review and approve executed batch records, Master Batch Records, and electronic batch record recipes.
* Review and approve technical documentation including 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 with 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.

Join a high-impact QA team where your expertise directly safeguards the quality, safety, and availability of life-changing biologic medicines for patients worldwide.

Date Posted31-Mar-2026

Closing Date18-Apr-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