Astellas is dedicated to creating treatments that make a meaningful difference in people's lives.
Our Patient-Centric Approach
We put patients at the heart of every decision we make, driven by our commitment to Patient Centricity. This guiding principle enables us to develop innovative health solutions through a deep understanding of the patient experience.
We believe that every staff member has a role to play in creating a patient-centric culture and integrating an awareness of the patient into our daily work, regardless of their role, team, or division.
Innovative Medicines for Improved Lives
We have pioneered groundbreaking medicines in immunology, oncology, and urology, extending and saving lives of cancer patients, making transplantation possible, and enhancing the quality of life for those living with often-overlooked conditions.
We take a patient-focused approach, allowing us to transform early science into treatments and solutions that directly improve and save patients' lives, from lab to clinic to patient.
The Opportunity
This position involves responsibility for preparing and executing validation activities, compliance of the plant, requires decision-making, and contributing to planning within the validation department.
The position holder will ensure that all validation activities are carried out to the highest standard in compliance with all relevant regulations, standards, and guidance.
Responsibilities
* Validation Scheduling: Assess validation requirements (new equipment, change controls, etc.), monitor project status, and ensure timely updates.
* Status Reports & Support: Maintain validation status through monthly reports and meetings, collaborating with project managers to adhere to schedules.
* Validation Standards: Ensure cGMP compliance, stay updated on validation innovations, and implement global and AICL, CSV documentation and procedures.
* Validation Execution & Approvals: Execute and approve validation protocols, review project change controls, and prepare necessary documentation and reports.
* General Responsibilities: Contribute to developing company validation standards and assist with department growth as needed.
* Regulatory & Audit Support: Present professionally to management and auditors, support SLC processes, and address queries during partner or regulatory inspections.
* Clear Communication & Justification: Effectively communicate and justify validation positions in SDLC discussions, applying relevant regulatory and industry knowledge.
* Logical Decision-Making: Approach topics logically, considering multiple perspectives and making informed decisions based on experience and expertise.
* Global Collaboration & Project Management: Work with global stakeholders, manage local validation projects, and contribute to larger cross-functional projects as a representative of the Validation team.
Education
* Third-level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.
This is a permanent full-time position, based in Tralee, Ireland. The successful candidate will be required to work 100% onsite/in the office.
Astellas is 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.