Description Quality Assurance SpecialistAbout Astellas: 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: Reporting to the Quality Assurance Manager, the chosen candidate will be required to work with Quality Assurance and staff to foster an ethos and culture of cGMP & Quality awareness.
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.
Essential Knowledge & Experience: 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.
Inspiring work climate.
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.