Senior Specialist QA

Job description

# **Senior Specialist, Quality Assurance** **Location:** Athlone, Ireland **Shift: 7 / 7 Shift** Week 1: 7am - 7pm (Mon, Tues, Sat, Sun) Week 2: 7am - 7pm (Wed, Thurs, Fri) **Help bring life-changing medicines to patients** At Alexion, quality is at the heart of everything we do. We are looking for a Senior Specialist, Quality Assurance to provide frontline Quality Assurance leadership and support across our manufacturing operations in Athlone. This is a highly visible, shift-based role where you will partner closely with Manufacturing, Quality Control, Engineering, Site Services, Planning, and Qualified Persons to ensure compliant, efficient, and uninterrupted product supply. As a trusted quality expert, you will provide real-time quality oversight, support critical decision-making on the production floor, and help ensure that every product released meets the highest standards of quality, safety, and compliance. You will also play a key role in driving operational excellence, digital transformation, and continuous improvement initiatives that enhance quality performance and support patient supply. **What you'll do** As a Senior Specialist, Quality Assurance, you will: - Provide quality leadership and technical expertise across manufacturing operations during your assigned shift. - Deliver direct, on-floor QA oversight to ensure activities are performed in accordance with cGMP requirements, approved procedures, and the site Quality Management System. - Act as the primary Quality Assurance contact during your shift, supporting timely quality decisions and escalation of critical issues. - Support manufacturing teams through real-time quality guidance, issue resolution, and risk-based decision-making. - Review manufacturing activities, documentation, investigations, and quality records to ensure compliance and quality standards are maintained. - Partner with stakeholders across Manufacturing, QC, Engineering, Planning, Site Services, and Quality functions to support reliable product supply. - Lead or support deviation investigations, root cause analysis activities, and the development of effective corrective and preventive actions (CAPAs). - Review and approve GMP documentation, including SOPs, validation documentation, master batch records, policies, and quality reports. - Provide quality oversight for validation, technology transfer, and new product introduction activities. - Support Qualified Person (QP) batch release activities and regulatory compliance requirements. - Contribute to inspection readiness activities and support internal, customer, and regulatory inspections. - Coordinate quality priorities across manufacturing areas and ensure effective shift handovers. - Drive continuous improvement initiatives that enhance compliance, efficiency, and right-first-time performance. - Analyse quality data, identify emerging trends, and provide insights to support informed decision-making. - Support the development and adoption of digital solutions, automation opportunities, and data-driven quality processes. - Help evaluate and implement innovative technologies, including artificial intelligence and advanced analytics solutions, within a compliant GxP environment. - Support training, coaching, and development activities across quality and manufacturing teams. - Mentor and guide colleagues on quality systems, compliance expectations, and digital tools. - Act as delegate for QA leadership colleagues when required. **Essential requirements** - Degree in Science, Pharmacy, Biotechnology, Engineering, or a related discipline, or equivalent relevant experience. - Significant experience working within pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments. - Strong understanding of cGMP requirements and Quality Management Systems. - Experience providing quality oversight within manufacturing, packaging, validation, Quality Control, or related operations. - Experience supporting investigations, deviation management, CAPAs, and risk assessments. - Ability to make sound, risk-based decisions in a fast-paced operational environment. - Strong analytical and problem-solving skills with the ability to manage complex quality issues. - Excellent communication, collaboration, and stakeholder management skills. - Ability to interpret regulatory requirements and apply them pragmatically within operational settings. - Strong organisational skills with the ability to manage multiple priorities and changing business needs. - Willingness and ability to work a designated shift pattern while supporting manufacturing operations. **Preferred experience** - Experience within sterile, aseptic, biological, or biopharmaceutical manufacturing environments. - Involvement in regulatory inspections, audits, and health authority interactions. - Experience supporting new product introductions, technology transfers, or validation programmes. - Knowledge of quality management systems such as TrackWise or similar platforms. - Experience using digital tools, reporting systems, data visualisation platforms, or analytics solutions to improve quality outcomes. - Experience supporting digital transformation initiatives within a regulated environment. - Familiarity with process improvement methodologies such as Lean, Six Sigma, or Operational Excellence frameworks. - Experience evaluating or implementing AI-enabled or advanced analytics solutions within a GxP environment. **Join us and help ensure every product we deliver meets the highest standards of quality, safety, and patient impact.** **Date Posted** 08-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.