About Astellas: We are making treatments that matter to people. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.
The Opportunity
As a Quality Engineer, you will support the operations department to ensure compliance with GMP/GDP requirements for an Aseptic fill-finish facility.
Your key responsibilities include ensuring adherence to regulations and guidance, industry best practices, and internal policies and procedures.
* 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.
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, 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.