QA Specialist, Biologics: GMP & Compliance

AstraZeneca plc; Dublin; On-site; EUR 85,000 - 120,000; Full time

Job summary

AstraZeneca plc in Ireland seeks an experienced QA professional to oversee end-to-end quality across manufacturing, testing, documentation, and product disposition in a Bulk Drug Substance facility.

You will partner with Operations, QC, Engineering, Supply Chain and QPs to embed quality in daily operations, drive continuous improvement, and ensure inspection readiness across the site.

Qualifications

• Fluent written and spoken English.
• Experience operating in a complex, international matrix environment.
• Experience in the pharmaceutical or biotech industry.
• Strong leadership presence with cross-functional influence.
• Solid understanding of GMP, quality systems and regulatory expectations.

Responsibilities

• cGMP Oversight for all commercial manufacturing activities in the Bulk Drug Substance facility.
• Review and approve executed and master batch records and electronic batch record recipes.
• Review and approve cleaning, process, and method validation documentation to strengthen robustness.
• Review and approve SOPs, work instructions, technical reports, and protocols.
• Participate in quality risk assessments and drive actions to reduce patient and business risk.
• Support inspection readiness and engage with health authority inspectors transparently.
• Oversee deviations, change control, calibration, and preventive maintenance.
• Author, review, and approve quality procedures to simplify compliance.
• Support supplier management activities to ensure a reliable external supply base.
• Review and release raw materials and components for manufacturing.
• Develop, track, and report quality metrics to drive accountability.
• Partner with Operations, QC, Engineering, Supply Chain and QPs to align teams with regulatory expectations.

Skills

English fluency

Communication

Cross-functional leadership

Pharma/biotech experience

GMP & regulatory knowledge

Quality systems

Education

Bachelor's in Pharmacy/Biology/Biotech/Engineering

Tools

MES systems

Electronic batch records

Job description

AstraZeneca plc in Ireland seeks an experienced QA professional to oversee end-to-end quality across manufacturing, testing, documentation, and product disposition in a Bulk Drug Substance facility.

You will partner with Operations, QC, Engineering, Supply Chain and QPs to embed quality in daily operations, drive continuous improvement, and ensure inspection readiness across the site.