Quality Assurance Validation

At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.

Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.

Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

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.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.

Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

The Opportunity:

The role is part of the Quality Assurance function within the Astellas Ireland Co. Ltd. Tralee Plant Aseptic Manufacturing Facility. The QA Validation resource will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Validation, Engineering, Manufacturing, Facilities, Document/Data Management, Quality Control (QC) and other GxP supporting functions to ensure compliance. This is accomplished by direct collaboration and oversight of Validation, Facilities/Engineering, Manufacturing Operations, QC activities and the review/audit of data and reports as specified by Standard Operating Procedures.

Responsibilities:

- Build strong relationships and collaboration between the Plant QA team and stakeholders, ensuring clear quality requirements from the start of projects.
- Provide hands-on QA support to staff, suppliers, and contractors, ensuring compliance with SOPs and GxP standards.
- Review and approve commissioning and qualification documents, including validation plans, risk assessments, and qualification protocols.
- Partner with the Validation team to define strategies and support the implementation of validation projects for new production facilities.
- Author, review, and approve controlled documents, including SOPs, specifications, protocols, and reports, ensuring quality in a cGMP environment.
- Participate in audits, manage Change Control systems, and support deviation investigations, CAPAs, and regulatory activities to ensure commercial readiness.
- Proficient in regional Good Manufacturing Practices (GMP) for pharmaceutical products.
- Knowledgeable in the technology used for manufacturing and testing biological products, with a focus on computerized systems.
- Experienced in pharmaceutical quality management systems (QMS), including tools like TrackWise, Valgenesis, and Vault.

Education:

- Science-based degree with experience in a cGMP compliance environment, experience of QA function in an aseptic manufacturing plant essential, or equivalent.

Additional information:

- This is a permanent, full-time position.
- Position is based in Tralee – Ireland.
- This position requires you to be 100% on-site/in 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.
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