Quality Engineer 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: 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.
Responsibilities: Ensure compliance with internal/external regulatory, legislative, and statutory requirements, promoting awareness across Operations.
Develop operational procedures for best practice and regulatory compliance; conduct risk assessments on processes and equipment.
Generate reports and data for Annual Product Quality Reviews, Regulatory submissions, customer complaint investigations, and periodic reviews.
Support internal/external audits, ensuring timely issue resolution, and raise/review non-conformances.
Provide quality technical support to Operations, including investigations, root cause analysis, and corrective actions to support production and schedule adherence.
Support plant operational activities, Change Control, commissioning/qualification, and work closely with QA regulatory departments for submissions.
Essential Knowledge & Experience: Experience in Pharmaceutical/Med Tech processes, with expertise in GMP manufacturing, investigations, and risk assessments.
Strong knowledge of audits, regulatory guidance, and Aseptic Fill Finish operations (advantageous).
Excellent interpersonal, communication, organisational, and planning skills, with a proactive, self-motivated approach.
Strong documentation practices, problem-solving abilities, and a flexible approach to ensure efficient departmental operations.
Education: Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.
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.
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