Unfortunately we do not offer sponsorship for this role.
Working hours: 39 hours per week, flexitime day shift. 10:00 - 15:00 Monday - Thursday, 09:00 - 14:30 Friday.
The primary focus of the Quality Specialist Engineer will be to support GMP operations by providing expert oversight and guidance on investigations, change controls, and compliance activities, ensuring adherence to regulatory standards and fostering continuous improvement within the maintenance and engineering functions.
- You will provide expert guidance and oversight on engineering investigations, change controls, deviations, and failure investigations within a GMP-regulated environment.
- You will review, assess, and approve engineering documentation, including change controls, investigation reports, SOPs, and other GMP-critical records.
- You will identify, document, and escalate quality or compliance issues, supporting the timely implementation of corrective and preventive actions.
- You will ensure Engineering activities are conducted in accordance with GMP requirements, site procedures, and safety policies, maintaining audit readiness at all times.
- You will coach, support, and deliver training to Engineering personnel on GMP compliance, investigation processes, and change control best practices.
- You will collaborate with cross-functional teams to drive continuous improvement, promote operational excellence, and ensure alignment with current regulatory and industry standards.