Astellas Quality Engineer
We are making treatments that matter to people. At Astellas, we put 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.
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.
We have developed ground-breaking, innovative medicines in immunology, oncology, and urology.
Our medicines extend and save lives of cancer patients, make transplantation possible, and improve quality of life for those living with conditions often overlooked.
We take a patient-focused approach, converting early science into treatments and solutions directly improving and saving patients' lives.
As a Quality Engineer, you will support the operations department to ensure compliance with GMP/GDP requirements for an Aseptic fill-finish facility.
Your role works closely with Validation, Engineering, Facilities, Quality Control (QC), and other supporting functions to ensure compliance.
Key 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 raising/reviewing 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.
* Excellent interpersonal, communication, organizational, 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 or equivalent.