QA Specialist (Days)

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

Are you ready to safeguard life-changing biologic medicines by owning end-to-end quality across manufacturing, testing, documentation, and product disposition? Join our Bulk Drug Substance facility and take accountability for ensuring every batch is safe, compliant, and ready for the patients who depend on us.

In this high-impact role, you will partner closely with Operations, QC, Engineering, Supply Chain and Qualified Persons to keep our Quality Management System strong and our site inspection-ready at all times. You will shape how quality is embedded in daily operations, influence decisions at pace, and help resolve complex challenges with clarity and confidence. How will you use your expertise to elevate both product quality and team performance?

Accountabilities

• cGMP Oversight: Provide quality and cGMP oversight for all commercial manufacturing activities in the Bulk Drug Substance facility, ensuring reliable supply and patient safety.
• Batch Record Governance: Review and approve executed and master batch records, including electronic batch record recipes, to enable right-first-time execution.
• Validation Governance: Review and approve cleaning, process, and method validation documentation to strengthen process robustness and compliance.
• Documentation Control: Review and approve SOPs, work instructions, technical reports, and protocols, driving clarity and standardization across the site.
• Risk Management: Participate in and provide QA oversight for quality risk assessments, prioritizing actions that reduce risk to patients and the business.
• Inspection Readiness: Support inspection readiness and engage directly with health authority inspectors, demonstrating a culture of transparency and continuous improvement.
• QMS Ownership: Oversee deviations, change control, calibration, and preventive maintenance to ensure timely closure, recurrence prevention, and sustained compliance.
• Procedure Leadership: Author, review, and approve quality procedures that simplify compliance and empower frontline teams.
• Supplier Quality: Support supplier management activities to maintain a reliable and compliant external supply base.
• Material Release: Review and release raw materials and components for manufacturing, safeguarding upstream quality.
• Performance Visibility: Develop, track, and report quality metrics to drive accountability, highlight trends, and guide decision-making.
• Cross-Functional Influence: Act as a key partner to Operations, QC, Engineering, Supply Chain and QPs, aligning teams to meet regulatory expectations and deliver for patients.

Essential Skills/Experience

• 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.

Desirable Skills/Experience

• Experience with biologics manufacturing and Bulk Drug Substance operations.
• Proficiency with electronic batch records and MES systems.
• Hands-on involvement in regulatory inspections and inspection readiness programs.
• Demonstrated expertise in quality risk management tools and methodologies.
• Background in supplier qualification and raw material lifecycle management.
• Familiarity with validation lifecycle (process, cleaning, analytical) and data integrity principles.

Why AstraZeneca:

Here, your work connects directly to people living with serious and often rare conditions, keeping their needs at the center of every decision. You’ll collaborate in a setting where unexpected teams gather in the same room to solve tough problems, combining the agility of a biotech environment with the scale and science of a global biopharma. We value kindness alongside ambition, encourage bold thinking backed by integrity, and equip you with modern technology and supportive leaders so you can turn high standards into real outcomes for patients and colleagues alike.

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.