At Astellas, we offer an inspiring place to work and the opportunity to make a meaningful difference for patients.
We combine our expertise in science and technology with a culture that is open, progressive and patient-centric. Our guiding principle is to support the development of innovative health solutions through a deep understanding of the patient experience.
Our Ethos
* **Patient Focus**: We put the needs of patients at the heart of everything we do.
* **Ownership**: We empower our staff to take ownership of their work and make decisions that drive results.
* **Results**: We strive to deliver high-quality outcomes that make a real difference to patients' lives.
* **Openness and Integrity**: We value transparency and honesty in all our interactions, both within and outside the company.
We are committed to creating an inclusive and respectful working environment that fosters collaboration and ownership.
The Opportunity:
As a Quality Assurance Specialist, you will play a key role in fostering a culture of cGMP & Quality awareness across management and staff. You will be responsible for ensuring site-wide compliance with cGMPs, including data integrity, and providing real-time support for manufacturing, QC, and operations.
Key Responsibilities:
* Foster a culture of cGMP & Quality awareness across management and staff.
* Ensure site-wide compliance with cGMPs, including data integrity.
* Provide real-time support for manufacturing, QC, and operations, including batch record review, deviation management, CAPA, and change management.
* Support warehouse operations with finished product labelling, shipping checks, and temperature mapping.
* Assist with internal/external audits and regulatory/customer inspections.
* Review and approve QA SOPs, plant, warehouse, and QC procedures, ensuring compliance with ISO 14001, Health & Safety, and Environmental regulations.
* Knowledge of regulatory requirements related to pharmaceutical manufacture.
* Able to work effectively using own initiative, have good organizational skills.
* Strong verbal and written communication skills.
Education:
* Third level qualification in Science or Engineering discipline, preferably with experience of working in a GMP environment; or equivalent.
What We Offer:
* A challenging and diversified job in an international setting.
* Opportunity and support for continuous development.
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.