About Astellas
At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges, placing the patient at the heart of everything we do. Through our global vision for Patient Centricity, we integrate the patient experience into our everyday working practices. We have developed ground breaking medicines in immunology, oncology and urology, improving and saving the lives of patients worldwide. Learn more at Astellas.com
Are you driven to make a real difference in the lives of patients?
We are seeking individuals who thrive in dynamic environments, embrace new ideas and are committed to making a meaningful impact.
Location and Working Environment
This position is 100% onsite in Tralee, Ireland.
Purpose & Scope
• The QC Operations Support Associate provides essential GMP QC support in a highly regulated Annex 1 aseptic manufacturing facility. The role ensures compliant execution of line clearance, environmental monitoring, water and clean steam sampling, and batch record review supporting sterile medicinal product.
• This position is critical to maintaining the facility’s Contamination Control Strategy (CCS), ensuring classified areas remain in a validated state and that all activities meet the expectations outlined in EU GMP Annex 1, EU GMP Vol. 4, and internal procedures.
The work schedule is subject to change to support business operations
Role and Responsibilities
• Carry out all tasks in accordance with Good Manufacturing Practices (GMP) and comply with all facility safety requirements.
• Perform line clearance and aseptic readiness checks, ensuring all interventions comply with the site Contamination Control Strategy.
• Execute Environmental Monitoring (EM) including viable and non-viable monitoring in Grade C & D cleanroom areas, and support EM investigations, root cause analysis, and CAPA activities.
• Conduct aseptic sampling of Purified Water, Water for Injection (WFI), and Clean Steam following validated procedures.
• Perform real-time and retrospective batch record reviews, ensuring process logbooks are complete and compliant with ALCOA+ data integrity principles.
• Maintain compliance and inspection readiness by managing documentation, authoring/updating procedures, owning deviations (non-conformances, CAPAs, change controls, OOS), and supporting cleanroom, gowning, aseptic process, and personnel qualifications in a cost-efficient manner.
Required Qualifications
• B.Sc. degree in Microbiology, Biotechnology or similar field.
Preferred 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 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.
Our Organizational Values and Behaviors
• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus
Benefits
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. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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