Quality Assurance for Integrated Batch Release

Quality Assurance for Integrated Batch Release

Date: Oct 2, 2026

Job Req Id: 17237

Location

IE

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

This position is 100% onsite in Tralee, Ireland.

Purpose and Scope

The role is part of the Quality Assurance function within the Astellas Ireland Co. Ltd. Tralee Plant Aseptic Manufacturing Facility. The QA resource will provide quality oversight and support for the qualification and validation of integrated GxP systems required to enable a compliant digital batch release process and review-by-exception operating model. The role will ensure that system design, configuration, integration, testing, data flows and associated controls meet applicable GxP regulations and guidance, data integrity requirements, industry best practices, local regulations, and internal policies and procedures. Working closely with Validation, Engineering, Manufacturing, Facilities, Digital/IT, Document and Data Management, Quality Control (QC), and other GxP-supporting functions, the role will review and approve qualification strategies, protocols, evidence, deviations, risk assessments and reports, and verify that system-generated data and exception-based review processes are accurate, complete, reliable and suitable to support batch disposition and release.

Role and Responsibilities

• Provide QA oversight and approval for the qualification and validation of integrated GxP systems, ensuring risk-based strategies, data integrity, GMP compliance, and readiness to support digital batch release and review-by-exception processes.
• Partner with Validation, Manufacturing, Laboratory, Quality, and system owners to define and approve requirements for digital batch release and review-by-exception, including CPP/CQA limits, exception and alarm management, audit trails, electronic records/signatures, data workflows, interfaces, traceability, access controls, segregation of duties, escalation, and contingency arrangements.
• Provide hands-on QA support to internal teams, suppliers, and contractors, ensuring compliance with GxP requirements, SOPs, validation expectations, and quality standards; support the development, review, and approval of GMP documentation, including specifications, protocols, reports, SOPs, deviations, CAPAs, and change controls.
• Collaborate with equipment owners, Validation, Engineering, and cross-functional stakeholders to ensure facility, equipment, software, and technical systems are appropriately qualified and validated, with effective quality requirements established from project initiation.
• Support regulatory and customer audits, regulatory communications, and collaboration with other QA organisations, Astellas sites, and relevant industry groups, ensuring effective communication and continued commercial and regulatory readiness.
• Provide QA leadership and influence across the plant, fostering a strong quality culture, supporting staff development, and ensuring QA activities and priorities align with business needs and GMP requirements.

Essential Qualifications

• Science based degree with experience in a cGMP compliance environment, experience of QA function in an aseptic manufacturing plant essential.
• QP Eligible preferably

Benefits

• Careers | Astellas

• Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

• Our Organisational Values and Behaviours

• Integrity

• Innovation

• Impact

• One Astellas

• Accountability

• Courage

• Sense of Urgency

• Outcome Focus

• Application notes

• 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.

• Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.

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