Quality Assurance Specialist

Quality Assurance Specialist, Systems About Astellas: At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. The Opportunity: Based in our Kerry Plant and reporting to the QA Systems Co-Ordinator, you as the Quality Assurance Specialist will be responsible for supporting compliance with cGMP regulations, as well as the development and maintenance of the Quality Management System. The position is therefore responsible for assisting with the ongoing development, implementation, and maintenance of cGMP compliance. Hybrid Working: At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office. Key Responsibilities: Promote cGMP & Quality awareness across all levels of management and staff, ensuring site-wide compliance. Support inspection readiness by ensuring timely, compliant progression of eQMS records. Provide real-time support for manufacturing, QC, and operations, including non-conformance management, root cause investigations, CAPA, and risk assessments. Assist with internal/external audits, regulatory inspections, and the customer complaints process. Review and QA approve SOPs and controlled documents for cGMP compliance across QA, plant, warehouse, and QC. Support supplier qualification, product quality reviews, major projects, and other quality-related activities, including training, investigations, and batch representative on major projects within AICL (KP), including LEAN/ OPEX activities. Other support areas include but are not limited to: quality investigations, TrackWise, ADMS authoring, training of new personnel and batch review activity, as assigned. Preferred Knowledge & Experience: Knowledge of regulatory requirements related to pharmaceutical manufacture. Exceptional attention to detail and organisational skills. Proficiency in Microsoft Office Suite, including MS Excel. Excellent communication and collaboration skills. Prior experience of working in a GMP environment. Education: Third level qualification in Science / Engineering discipline or equivalent. Additional information: This is a 6-month fixed-term contract. Position is based in Killorglin, Co. Kerry. This position requires you to be onsite a minimum of 3 days a week. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Ireland #LI-Hybrid To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.