Astrazeneca

Actively Hiring

Others

Dublin, Ireland

Full-time

Role Overview

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.

About Astrazeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world's serious diseases.

Key Responsibilities

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.

Requirements & Eligibility

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.
Degree in Pharmacy, Biology, Biotechnology, Engineering, or another relevant scientific discipline.

Required Skills & Tech

cGMPQuality Management SystemQuality Risk AssessmentsDeviation ManagementChange Control