
About this role
At Astellas, we make treatments that matter to people, tackling the toughest health challenges with Patient Centricity at the heart of everything. The QC Chemist role involves conducting analytical testing in manufacturing to ensure cGMP compliance. Join us to make a real difference in patients' lives through ground-breaking medicines in immunology, oncology, and urology.
Daily responsibilities include performing and reviewing analytical testing on raw materials, in-process, final products, and stability samples with accurate reporting. Maintain QC operations through sampling, instrument calibration, validation, troubleshooting, root cause analysis, and CAPA implementation. Drive continuous improvement in a fully compliant environment.
This 100% onsite position in Dublin, Ireland, suits those who thrive in dynamic settings with strong collaboration across QC leadership and stakeholders. Embrace a safety culture while supporting audits, projects, and inventory management. Work within a global team committed to regulatory excellence.
Experience global collaboration with like-minded life-science leaders and real-world patient impact via transformative therapies. Engage in relentless innovation at the forefront of scientific advancement. Benefit from a culture of growth supporting your development and ambitions.
Requirements
- Third level qualification in relevant field or proven relevant experience
- Strong independent working ability with effective communication and collaboration across QC leadership and stakeholders
- In-depth knowledge of GMP, pharmacopeia, and regulatory requirements, including audit and inspection readiness
- Data-driven mindset with Lean Six Sigma skills to support decision-making and continuous improvement
- Proven leadership, planning, and problem-solving capabilities
- Solid analytical chemistry expertise with commitment to ongoing technical development
- Excellent organisational, training, coaching, presentation, and technical writing skills
Responsibilities
- Conduct and review analytical testing of raw materials, in-process, final products, and stability samples, ensuring accurate reporting and full cGMP/regulatory compliance
- Maintain and optimize QC operations including sampling, instrument calibration/validation, troubleshooting, root cause analysis, and CAPA
- Support continuous improvement initiatives in QC processes
- Support quality systems and team activities such as procedures, audits, projects, inventory management, safety culture, and regulatory compliance
- Ensure audit and inspection readiness through in-depth GMP and pharmacopeia knowledge
- Apply data-driven mindset with Lean Six Sigma skills for decision-making
Benefits
- 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
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