Materials Quality Engineer - Pharma

IrishJobs

Ireland

Ireland

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À propos

Materials Quality Engineer - Pharma About Astellas At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges, placing the patient at the heart of everything we do. Through our global vision for Patient Centricity, we integrate the patient experience into our everyday working practices. We have developed ground breaking medicines in immunology, oncology and urology, improving and saving the lives of patients worldwide. Learn Are you driven to make a real difference in the lives of patients? We are seeking individuals who thrive in dynamic environments, embrace new ideas and are committed to making a meaningful impact. Location and Working Environment This position is 100% onsite in Tralee, Ireland. Purpose & Scope 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. Role and Responsibilities Ensure Operations compliance with all regulatory, legislative, statutory, and internal quality requirements through robust procedures, risk assessments, and continuous improvement initiatives. Generate and analyse operational data, quality reports, KPIs, and documentation to support product quality reviews, regulatory submissions, customer complaints, and periodic reviews. Lead and support investigations into non-conformances, quality issues, and root cause analysis, implementing corrective and preventive actions within the QMS. Provide technical quality support to manufacturing operations, including expertise in aseptic filling and lyophilisation, to maintain production efficiency and schedule adherence. Support operational projects, change controls, commissioning/qualification activities, audits, and cross-functional initiatives to ensure compliance and operational excellence. Communicate effectively with Operations leadership by reporting progress, escalating risks or quality concerns, attending meetings, and providing timely feedback on operational performance. Required Qualifications Third level qualification in a Science or Engineering discipline. Preferrable experience Proven experience within Pharmaceutical/MedTech GMP manufacturing environments, including investigations, risk assessments, audits, and regulatory compliance activities. Strong understanding of quality systems, documentation practices, and regulatory requirements, with aseptic fill-finish knowledge considered advantageous. Excellent communication, organisational, and problem-solving skills, with a proactive, flexible approach and the ability to work independently. What awaits you at Astellas? Global collaboration and connection with like minded life science leaders. Real world patient impact through transformative therapies. Relentless innovation at the forefront of scientific advancement. A culture of growth that supports your development and ambitions. Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits Career | Astellas 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. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. #LI-Onsite #LI-Tralee #LI-EN1 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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Ireland

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English

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