Quality Assurance Specialist - Integrated Batch Release

About Astellas Pharma

Astellas Pharma is a global life sciences company focused on transforming innovative science into real value for patients. Our therapeutic areas include oncology, ophthalmology, urology, immunology, and women's health. Through robust research and development efforts, we strive to create new solutions for diseases with significant unmet needs.

Role Summary

This position is based full-time onsite at our Tralee, County Kerry facility in Ireland. It operates within the Quality Assurance function at the Tralee Plant Aseptic Manufacturing Facility. The role involves providing quality oversight and support for the qualification and validation of integrated GxP-compliant digital systems that facilitate a compliant digital batch release and review-by-exception model. It ensures all system design, configuration, integration, testing, and data flows adhere to relevant GxP regulations, data integrity expectations, industry standards, local laws, and internal policies.

Key Responsibilities

• Offer QA oversight and approval for qualification and validation activities of integrated GxP systems, ensuring risk-based approaches, data integrity, GMP compliance, and readiness to enable digital batch release and review-by-exception workflows.
• Collaborate with Validation, Manufacturing, Laboratory, Quality departments, and system stakeholders to define and approve digital batch release requirements including critical process parameters, exception management, audit trails, electronic records, data workflows, access controls, segregation of duties, escalation protocols, and contingency plans.
• Provide hands-on QA support to internal teams and third-party suppliers and contractors to ensure compliance with GxP principles, SOPs, validation criteria, and quality standards; assist in preparing, reviewing, and approving GMP documentation such as specifications, protocols, reports, SOPs, deviations, CAPAs, and change controls.
• Work alongside equipment owners, validation teams, engineering, and other cross-functional stakeholders to guarantee proper qualification and validation of facilities, equipment, software, and technical systems, embedding quality requirements early in projects.
• Support regulatory and customer audits, maintain regulatory communications, and collaborate with other QA organizations, Astellas sites, and industry groups to sustain commercial and compliance readiness.
• Lead and influence QA culture plant-wide, promoting strong quality values, supporting professional growth of staff, and aligning QA operations with business objectives and GMP standards.

Qualifications and Eligibility

• Degree in a science-related field coupled with experience in a current Good Manufacturing Practice (cGMP) environment; prior QA experience in an aseptic manufacturing setting is essential.
• Preferably eligible to be a Qualified Person (QP).

Company Culture and Benefits

• Collaborate globally within a community of like-minded life science professionals dedicated to improving patient outcomes worldwide.
• Impact real-world patient health by contributing to innovative therapies delivered on a global scale.
• Be part of a pioneering company leading scientific breakthroughs in healthcare.
• Enjoy a growth-oriented culture that supports contribution, development, and empowerment in pursuing professional passions.

Core Values

• Integrity
• Innovation
• Impact
• One Astellas (collaborative mindset)
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus

Equal Opportunity Statement

Astellas is committed to equal employment opportunities regardless of race, color, religion, sex, national origin, disability, veteran status, or any legally protected category.