QA Specialist – Biotech/Pharma (Day Shift)

Alexion Pharma Spain S.L.; Dublin; Hybrid; EUR 70,000 - 95,000; Full time

Job summary

AstraZeneca in Dublin is seeking a QA Specialist (Days) to own end-to-end quality across manufacturing, testing, documentation, and product disposition. You will partner with Operations, QC, Engineering, Supply Chain and QPs to keep the QMS robust and inspection-ready.

You will oversee cGMP, batch records, validation, documentation, and risk management while driving continuous improvement and timely regulatory compliance across a high-profile biopharma site.

Qualifications

• Fluency in written and spoken English.
• Experience in the pharmaceutical or biotech industry.
• Ability to work in an international matrix environment.
• GMP knowledge and regulatory understanding.

Responsibilities

• Provide quality and cGMP oversight for commercial manufacturing activities.
• Review and approve batch records to enable right-first-time execution.
• Review validation documentation including cleaning, process and method validation.
• Review SOPs, work instructions, and protocols to drive standardization.
• Participate in quality risk assessments and drive actions to reduce patient/regulatory risk.
• Support inspection readiness and engage with health authority inspectors.
• Oversee deviations, change control, calibration, and preventive maintenance.
• Support supplier quality and release of materials.
• Develop and report quality metrics to guide decisions.
• Collaborate with Operations, QC, Engineering, Supply Chain and QPs.

Skills

English fluency

Communication

Matrix environment

Pharma/biotech experience

Leadership

GMP knowledge

Regulatory awareness

Education

Degree in Pharmacy, Biology, Biotechnology, Engineering, or related field

Tools

Electronic batch records

MES systems

Job description

AstraZeneca in Dublin is seeking a QA Specialist (Days) to own end-to-end quality across manufacturing, testing, documentation, and product disposition. You will partner with Operations, QC, Engineering, Supply Chain and QPs to keep the QMS robust and inspection-ready.

You will oversee cGMP, batch records, validation, documentation, and risk management while driving continuous improvement and timely regulatory compliance across a high-profile biopharma site.