Quality Assurance Validation
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 are seeking individuals who thrive in dynamic environments, embrace new ideas and are committed to making a meaningful impact.
Location and Working Environment
- This position is 100% onsite in Tralee, Ireland.
Purpose & Scope
- The role is part of the Quality Assurance function within the Astellas Ireland Co. Ltd. Tralee Plant Aseptic Manufacturing Facility. The QA Validation resource will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Validation, Engineering, Manufacturing, Facilities, Document/Data Management, Quality Control (QC) and other GxP supporting functions to ensure compliance. This is accomplished by direct collaboration and oversight of Validation, Facilities/Engineering, Manufacturing Operations, QC activities and the review/audit of data and reports as specified by Standard Operating Procedures.
Role and Responsibilities
- Build strong cross-functional relationships to ensure clear quality requirements and effective collaboration from project start.
- Provide hands-on QA oversight to staff and contractors, ensuring compliance with SOPs and GxP standards.
- Review and approve validation lifecycle documentation (plans, specifications, risk assessments, protocols, reports, deviations, and change controls).
- Partner with validation and stakeholders to define strategies, support project execution, and ensure timely, high-quality facility readiness in a cGMP environment.
- Author, review, and manage QA documentation and quality system records (SOPs, deviations, CAPA, change controls), including leading investigations and audits.
- Support leadership, external communications, and quality culture development while ensuring regulatory engagement and continuous improvement.
Required Qualifications
- Science based degree with experience in a cGMP compliance environment, experience of QA function in an aseptic manufacturing plant essential.
- QP eligibility is an advantage.
What awaits you at Astellas?
- Global collaboration and connection with like‑minded life‑science leaders.
- Real‑world patient impact through transformative therapies.
- Relentless innovation at the forefront of scientific advancement.
- A culture of growth that supports your development and ambitions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
Learn more at: https://www.astellas.com/en/careers
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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