About this role
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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.
Working Environment and Location
- This position is onsite in Killorglin, Co.Kerry
Working Hours
- This position is full time
- This position is a 2 year graduate role starting early September 2027
Purpose and Scope
The main functions of this position are to ensure product produced for our patient is of the highest quality and meets all predetermined requirements and standards
Role and Responsibilities
Line Clearance
- Execution of Line Clearance checks in accordance with approved procedures and GMP requirements.
- Assessment and reporting of any critical or non-critical line clearance incidents.
Batch Record Review
- Ensures that batch records are reviewed promptly in accordance with SLAs
- Performs thorough quality reviews of batch records so as to ensure that all batches are suitable for release by the QP.
- Documents and reports batch record errors to Production in order to reduce the number of errors occurring.
Quality Representative (Production)
- Participation in SDI meetings
- Ensures effective investigation and assessment of quality issues and productivity initiatives associated with the Production & Engineering
- Demonstrates a thorough knowledge of the respective process, procedures, equipment and controls.
- Liaises with departments on the shop floor level in order to prevent quality issues arising.
- On line quality impact assessments
- Involvement in Risk Assessment, as required.
Other tasks in
Process Orders
- Completion of Cleaning Validation activities
- Preparation and maintenance of the weekly shipping schedule
- Lead or participate in lean initiatives as required.
- Quality Management System
- Quality investigations
- Document Authoring
- Completion of eQMS records
Essential Qualifications
- Must have finished a Bachelor Degree in a Science or equivalent in time for a September 2027 start date
Benefits
Careers | Astellas
Why Astellas
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
Values: Integrity, Innovation and Impact sit at the heart of what we do.
Behaviors: We come together as ‘One Astellas’ , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.
Our Organisational Values and Behaviours
Integrity Innovation Impact One Astellas Accountability Courage Sense of Urgency Outcome Focus
## Skills and Capabilities
Organizational Focus
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We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, 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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