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Athlone, Éire / Ireland
Hybrid
The QA Validation Specialist performs review and approval activities to support validation activities in Alexion ARDU cGMP commercial and clinical requirements for the Alexion Manufacturing Facility. The responsibilities will include performing review and approval of validation documents such as policies, master plans, procedures, specifications, investigations, protocols and reports.
Maintenance of a strong Quality culture throughout the project through operational activities.
Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
Lead and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations.
Participate in verification quality risk assessments and provide quality oversight to ensure
verification quality risk assessments are effectively maintained/controlled.
Ensure and participate in the Quality Assurance support to internal manufacturing and technical
groups. Review and approval of functional area documentation (SOP, Work Instructions,
Criticality Assessments, technical report and protocols).
Authoring, review and approval of QA validation -related procedures.
Review and approve Validation protocols as required. (Examples include cleaning, process, and method validation).
Support the vendor quality management programme.
Complete Audits as required.
Develop and report quality metrics for validation/verification.
Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
Primary Degree in Science
Post-graduate studies as appropriate to augment primary degree
3-5 years’ experience in Quality/validation environment. Drug Product and Drug Substance experience
Excellent attention to detail
Good communication, team work and problem solving skills
The duties of this role are generally conducted in an office environment and in a pharmaceutical manufacturing environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
As is typical of a pharmaceutical manufacturing-based role, employees must be able, with or without an accommodation to: frequently lift/carry 15/30 pounds unassisted/assisted; stand for prolonged periods of time; walk and move for prolonged periods of time; climb stairs or ladders; gown/degown PPE and uniforms; use a computer with a keyboard and mouse; collaborate with others; maintain general availability during standard business hours.
Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
Good knowledge of relevant computer packages e.g. Trackwise, SAP and Vault Quality
Date Posted
12-Aug-2026Closing Date
25-Aug-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.