Quality Assurance Systems Graduate

Description Quality Assurance Systems Graduate 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 will be responsible for supporting compliance with cGMP regulations, as well as the development and maintenance of the Quality Management System. In this role, you will assist with the ongoing development, implementation, and maintenance of cGMP compliance. Responsibilities

• Foster a culture of cGMP & Quality awareness across management and staff.
• Support site-wide compliance with cGMPs, including data integrity.
• Support inspection readiness through timely and compliant progression of eQMS records.
• Provide real-time support for manufacturing, QC, and operations: including non-conformance management, root cause investigations, risk assessments, CAPA and effectiveness checks.
• Assist with internal/external audits and regulatory/customer inspections.
• Support the customer complaints process, including investigation progression and final reports.
• Support supplier qualification process and related risk management.
• Review and approve SOPs/ controlled documents for QA, plant, warehouse, and QC; ensuring cGMP compliance.
• Compilation of inspection readiness metrics.
• Support the Product Quality Review process.
• QA support for 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.

Essential Knowledge & Experience

• Exceptional attention to detail and organisational skills.
• Proficiency in Microsoft Office Suite, including MS Excel.
• Excellent communication and collaboration skills.
• Ability to manage multiple tasks and deadlines effectively.

Education/Qualifications

• Third-level qualification in the Science discipline or equivalent

Additional Information

• 2 years fixed-term contract starting on 1st September 2026
• This position is on-site based in the Kerry plant, Killorglin, Ireland. Candidates must be located within a commutable distance of the office.

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.