Quality Assurance Specialist

2 weeks ago

Ireland Astellas Ireland Full time

Quality Assurance Specialist About Astellas: At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. 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. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. The Opportunity: You will be reporting to the Quality Assurance Manager and will be required to work with Quality Assurance and other staff to foster an ethos and culture of cGMP & Quality awareness. Essential Knowledge & Experience: 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. Preferred 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. Additional information: This is a permanent, full-time position. Position is based in Dublin, Ireland. This position requires you to be 100% onsite/in the office. What We Offer: A challenging and diversified job in an international setting. Opportunity and support for continuous development. Inspiring work climate. 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. #LI-Tralee #LI-Onsite #LI-LL1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

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