Senior QA Specialist (Extended Days)

Alexion Pharmaceuticals View all jobs

  • Dublin
  • Permanent
  • Full-time
  • 16 days ago
Senior QA Specialist (Extended Days)Location: College Park, DublinShift Pattern: 2 x day shifts (7am-7pm), 2 x late shifts (12pm-12am), followed by 4 days offAbout the RoleWe're seeking a Senior QA Specialist to provide advanced quality oversight for our Bulk Drug Substance (BDS) facility at ADMF. In this role, you'll ensure that manufacturing, testing, labelling, and storage activities meet all regulatory and GMP requirements, while supporting a robust Quality Management System across the site.You'll partner closely with Operations, QC, Engineering, Facilities, Supply Chain and QPs to maintain compliance, support inspection readiness, and ensure uninterrupted patient supply. As a senior member of the team, you'll also act as a point of contact for QA Specialists and deputise for the QA Manager when required.This is a shift-based position operating across extended days and evenings, offering a dynamic working rhythm.What You'll Do
  • Provide quality and cGMP oversight for all commercial manufacturing activities in the BDS and warehouse facility.
  • Review and approve executed batch records, Master Batch Records, and electronic batch record recipes.
  • Review and approve technical documentation including cleaning, process, and method validation.
  • Review and approve SOPs, work instructions, technical reports, and protocols.
  • Lead and participate in quality risk assessments, ensuring risks are effectively controlled.
  • 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.
  • Act as a senior point of contact for QA Specialists, providing guidance and support.
  • Deputise for the QA Manager during periods of absence.
  • Perform additional duties as required by management.
What You Bring
  • Fluency in written and spoken English.
  • Strong communication and presentation skills, with the ability to influence at all levels.
  • Proven ability to operate effectively in a complex, international matrix environment.
  • Significant experience in a biologics quality function, preferably drug substance, with increasing responsibility.
  • Strong leadership presence and interpersonal influencing skills.
  • Deep understanding of GMP, quality systems, and regulatory expectations.
  • Demonstrated success in auditing and process improvement.
  • Experience working in a Lean or Six Sigma environment.
  • Proficiency with SAP, EDMS, and MES systems.
Education
  • Degree in Pharmacy, Biology, Biotechnology, Engineering, or another relevant scientific discipline.
Step into a senior QA role where your expertise directly safeguards the quality, safety, and availability of life-changing biologic medicines, all within a high-performing team that values ownership, collaboration, and continuous improvement.Date Posted 31-Mar-2026Closing Date 17-Apr-2026Our 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.

Alexion Pharmaceuticals