QA Specialist - 24 Month Secondment/FTC

Job description

# **QA Specialist – 24 Month Secondment/FTC** **Location:** Athlone, Ireland **Shift:** 23:00–07:15, Monday, Tuesday, Wednesday, Thursday, and Sunday **Be trusted to go further.** At Alexion, we are driven by our commitment to transforming the lives of patients with rare diseases. As a QA Specialist, you will play a critical role in ensuring our medicines are manufactured, tested and supplied to the highest quality standards, helping us deliver life-changing treatments to patients around the world. This is a shift-based role providing direct Quality Assurance oversight of manufacturing operations within our Bulk Drug Substance (BDS) and Drug Product (DP) facility in Athlone. You will serve as the primary Quality representative during your assigned shift, offering real-time support, quality guidance and decision-making to manufacturing teams while helping maintain compliance with global regulatory and cGMP requirements. Working closely with Operations, Quality Control, Technical Services and Engineering, you will contribute to the successful manufacture and release of commercial and clinical products while supporting continuous improvement, digital transformation and operational excellence. **What you'll do** In this role, you will: - Provide QA oversight and cGMP support for manufacturing activities across the Drug Substance and Drug Product facilities. - Deliver on-floor Quality Assurance support during manufacturing operations, ensuring compliance with approved procedures, regulatory requirements and the Quality Management System (QMS). - Act as the primary Quality contact during your assigned shift, providing real-time quality guidance, issue escalation and quality decision-making. - Assess manufacturing events, deviations and exceptions, evaluating potential impacts to product quality, patient safety, compliance and supply. - Participate in shift handovers, ensuring effective communication of quality risks, manufacturing issues and open actions. - Review and approve quality and technical documentation, including SOPs, work instructions, technical reports, protocols and validation documentation. - Support quality risk management activities and ensure risk assessments remain effective and compliant. - Review and approve Master Batch Records in line with GMP principles and company procedures. - Support inspection readiness activities, regulatory inspections and responses to inspection observations. - Provide oversight of Quality Management System activities, including deviations, CAPAs, change controls and preventative maintenance programmes. - Support vendor and supplier management activities and raw material qualification programmes. - Develop, monitor and report quality metrics that drive operational excellence and compliance. **Supporting Digital Innovation** You will also play an active role in advancing digital and data-driven quality practices by: - Supporting the digitalisation of Quality Assurance and manufacturing oversight processes. - Using approved digital tools, reporting systems and analytics to strengthen quality oversight and continuous improvement. - Supporting the implementation, validation and lifecycle management of digital technologies used within GMP environments. - Contributing to the compliant adoption of AI-enabled and advanced analytics solutions in accordance with GxP, data integrity and governance requirements. - Promoting effective use of approved digital and AI-enabled tools through testing, training, user engagement and change management activities. **Essential requirements** - Bachelor's degree in Science, Engineering or a related discipline, or equivalent combination of education and experience. - Experience in a Quality Assurance environment within the pharmaceutical, biopharmaceutical or related industry. - Strong knowledge of cGMP requirements and pharmaceutical manufacturing regulations. - Experience supporting GMP operations and interacting with regulatory frameworks including FDA, HPRA or equivalent authorities. - Excellent attention to detail and a commitment to quality and compliance. - Experience using electronic quality management systems such as TrackWise or similar platforms. - Strong planning, organisational and prioritisation skills. - Excellent communication and stakeholder management skills. - Ability to work effectively within a shift-based environment supporting manufacturing operations. **Desirable requirements** - Experience in sterility assurance and aseptic manufacturing environments. - Knowledge of drug substance and/or drug product manufacturing processes. - Experience supporting digital transformation, process automation, reporting dashboards or data analytics initiatives within a GMP environment. - Experience participating in the implementation or validation of digital, automated or AI-enabled quality systems. - Experience supporting regulatory inspections and audit activities. - Strong technical capabilities in pharmaceutical manufacturing, compliance and quality systems. **Why Alexion?** Every day, our work has the potential to impact patients living with rare diseases worldwide. You'll join a collaborative and innovative environment where quality, science and technology come together to deliver medicines that make a meaningful difference to people's lives. If you're passionate about quality, compliance and continuous improvement, and want to be part of a team committed to delivering excellence for patients, we'd love to hear from you. **Apply today and help us deliver life-changing medicines to those who need them most.** **Date Posted** 03-Sept-2026 **Closing Date** 17-Sept-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.