Quality Assurance Validation Specialist
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.
Location and Working Environment
- This position is onsite in Killorglin, Ireland.
- Working Hours
- Part‑Time: 0.6 FTE (Wednesday, Thursday, Friday).
Purpose & Scope
- This role supports the development, improvement and control of GxP validation activities, ensuring compliance with site procedures and regulatory requirements. It includes QA governance, review and approval of validation documentation, and management of GxP change control processes.
Role and Responsibilities
- Assessment of current practices to ensure compliance with GMP requirements.
- Familiarisation with developments and innovations in validation requirements.
- Review of procedures, reports and results for compliance.
- Review and approval of validation documents (URS, Validation Plans, OQ, PQ, Validation Reports).
- Review and approval of change controls and routine validations.
- Preparation of Periodic Review Reports.
- Participation in project teams ensuring validation meets internal procedures and GMP principles.
- Biannual Trend Review of GxP site change controls.
- QA management of GxP change control processes to maintain validated state.
- QA management of Computerised System Periodic Reviews.
- Generation of Product Quality Reviews for GxP change control activities.
Required Qualifications
- BSc or equivalent academic qualification.
Preferred Qualifications
- Knowledge of regulatory requirements for validation including aseptic processing, computerised systems, manufacturing processes, equipment and QC testing.
- Industrial or pharmaceutical experience is an advantage.
What awaits you at Astellas?
- Global collaboration: Work within a connected global community dedicated to improving patient lives.
- Real-world patient impact: Contribute to life-changing therapies that make a difference worldwide.
- Relentless innovation: Join a company pushing scientific boundaries.
- A Culture of Growth: Thrive in a supportive environment that fosters development and progression.
Our Organisational Values and Behaviours
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
Careers | Astellas
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.
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