Quality Operations Graduate

Description Quality Operations Graduate About Astellas At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. The Opportunity As a Quality Operations Graduate, your main function is to ensure the product produced for our patients is of the highest quality and meets all predetermined requirements and standards Responsibilities And Accountabilities 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.
• Coaching & Advising line operating personnel on compliance requirements & best practice

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

Education/ Qualifications

• Bachelor's Degree in a Science or equivalent

Preferred Qualifications

• Industrial/ Pharmaceutical experience would be advantageous

Additional Information

• 2 years fixed-term contract starting on 1st September 2026
• This position is on-site based in Kerry plant Killorglin, Ireland. Candidates must be located within a commutable distance of the office.

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.