Quality Engineer 12 month FTC
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
- Position is based in Tralee – Ireland
- This position requires you to be 100% on site / in the office
- Willing to work additional hours and/or travel as required by the business.
Purpose and Scope
The role of the Quality Engineer will be to support the operations department to ensure compliance with GMP/GDP requirements for an Aseptic fill finish facility. Responsibilities include ensuring adherence to regulations and guidance, industry best practices, internal policies and procedures. This position works closely with Validation, Engineering, Facilities, Quality Control (QC) and other supporting functions to ensure compliance.
Responsibilities and Accountabilities
Department Operation:
- Ensure compliance with internal/external regulatory, legislative, and statutory requirements, promoting awareness across Operations.
- Develop operational procedures for best practice and regulatory compliance; conduct risk assessments on processes and equipment.
- Generate reports and data for Annual Product Quality Reviews, Regulatory submissions, customer complaint investigations, and periodic reviews.
- Support internal/external audits, ensuring timely issue resolution, and raise/review non-conformances.
- Provide quality technical support to Operations, including investigations, root cause analysis, and corrective actions to support production and schedule adherence.
- Support plant operational activities, Change Control, commissioning/qualification, and work closely with QA regulatory departments for submissions.
Required Qualifications
- Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.
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 help people worldwide.
- Relentless innovation: Be part of an organisation pushing scientific and operational boundaries.
- A Culture of Growth: Thrive in a supportive workplace that values 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. Authentic communication will only originate from verified company email addresses or official LinkedIn profiles.
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