About this role
Quality Engineer
Description
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Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
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Are you driven to make a real difference in the lives of patients?
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We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
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Working Environment and Location
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Position is based in Tralee - Ireland
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This position requires you to be 100% on site / in the office
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Willing to work additional hours and/or travel as required by the business.
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At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
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Purpose and Scope
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The role of the Quality Engineer will be to support the operations department to ensure compliance with GMP/GDP requirements for an Aseptic fill finish facility. Responsibilities include ensuring adherence to regulations and guidance, industry best practices, internal policies and procedures. This position works closely with Validation, Engineering, Facilities, Quality Control (QC) and other supporting functions to ensure compliance.
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Role and Responsibilities
Department Operation:
- Ensure compliance with internal/external regulatory, legislative, and statutory requirements, promoting awareness across Operations.
- Develop operational procedures for best practice