Posted on Jun 3, 2021 by Elevate Direct
This is a full time position, reporting to the Plant Engineering AD. The Quality Engineer will be responsible for coordinating the Engineering Departments GMP requirements both in the Project Phase and then transitioning into Sustaining Phase. The Quality Engineer will be responsible for ensuring that the Engineering Department, as a whole, is compliant with all GMP requirements as well as co-ordinating the Department's quality system needs, eg investigations, change controls, action completion and effectiveness as well as audit readiness and documentation compliance.
- Provide structure, organisation and visibility to the Engineering Department's TrackWise requirements, co-ordinating demands so that items are closed effectively, in full and on time.
- Act as the department SME for root cause analysis techniques, investigation reporting and change control planning; providing training to the engineering department as well as oversight of the same.
- Responsible for audit readiness within the Engineering Department acting as internal auditor, providing assistance and guidance to the department to improve on compliance and audit readiness state.
- Responsible for co-ordinating the Engineering Departments documentation needs; creating a handover process from project to sustaining, providing organisation and visibility to ensure the department have an effective and lean documentation handling process.
- Responsible for coordinating the Engineering Departments training needs and working with the Site Training Lead to ensure the Engineering Department is compliant and trained effectively.
- Lead vendor assessments and ensure vendors are delivering a compliant and efficient service.
- Improving GMP compliance and best practices in a lean and efficient manner within the Engineering Team
- Developing and maintaining associated metrics. Creating a roadmap for the department and tracking against roadmap.
- Creating and chairing an Engineering Quality Forum to help improve compliance and drive continuous improvement within the Group
- Minimum of 5 years' experience in a highly regulated environment (Bioparmaceutical preferred) is preferable
- Experience with a start-up or Greenfield site and the implementation of new systems
- Completing audits of external third party vendors
- Preferably a third level qualification in Engineering/Quality/Science.
- Demonstrated experience in implementing GMP compliance in engineering setting in a Pharmaceutical environment.
- Proven audit experience with external client and regulatory bodies as well as an internal auditor.
- Technical ability in root cause analysis, statistical analysis and technical report writing.
- Strong metrics management abilities.
- Must be able to work with a variety of teams, made up of both technical and non-technical personnel.
- Ability to efficiently use current computer packages in particular Excel, PowerPoint, MS Project and Word.
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