QA Specialist – 12 Month FTC

Alexion Pharmaceuticals, Inc.; Dublin; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Alexion Pharmaceuticals, Inc. is seeking a QA Specialist for our Bulk Drug Substance facility in Dublin. You will provide end-to-end quality oversight across manufacturing, testing, documentation and product disposition, ensuring每 batch is safe, compliant and ready for patients.

You will review batch records, validate documentation, manage deviations and support inspections while collaborating with a global team to uphold GMP and regulatory expectations.

Competenze

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

Mansioni

• Provide quality and cGMP oversight for commercial manufacturing activities in the BDS facility.
• Review and approve batch records and electronic batch record recipes.
• Review and approve validation documents and SOPs, work instructions, and technical reports.
• Participate in QA oversight for risk assessments and deviations.
• Support inspection readiness and liaise with health authority inspectors.
• Oversee deviations, change control, calibration and preventive maintenance in QMS.
• Author and approve quality procedures and supplier management activities.
• Review and release raw materials and components for manufacturing.
• Develop, track and report quality metrics.

Conoscenze

Quality oversight

cGMP knowledge

Documentation review

Communication skills

Cross-functional collaboration

Regulatory readiness

Formazione

Pharmacy/Biology/Biotech degree

Descrizione del lavoro

About The Role

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. This is a high‑impact role at the heart of our biologics operation — ensuring every batch we produce is safe, compliant, and ready for patients who rely on us.

Location

College Park, Dublin

Reports To

QA Manager

What You’ll Do

• 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.
• 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 and 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.

Play a pivotal role in safeguarding the quality of life‑changing biologic medicines, where your expertise directly protects patients and strengthens a world‑class manufacturing site.

Date Posted

01-Oct-2026

Closing Date

14-Oct-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.