Quality Engineer Biopharmaceuticals
A superb opportunity has arisen to join a growing and successful biopharmaceutical company as a quality engineer. As the quality engineer you will be responsible for ensuring compliance for the company with the quality management system by interacting with different departments including Engineering and Calibration and of course Quality Assurance. You will also bring with you ideas for improvement and be able to deputise for the line manager and take on training responsibilities.
A leading and growing biopharmaceutical manufacturer, our client has their own product portfolio as well as operating as a contract manufacturer. With over 250 people in the business, they are continuing to expand across all of the business functions.
Main duties and responsibilities
- To manage the company’s Quality Management System for the engineering department including Maintenance and Calibration functions
- Training staff
- Participate in internal and external audits
- Maintain SOP’s and manage the on time closure of change controls and risk assessments
- Lead failure investigations
- Internally report on the performance of the Quality Managements metrics
Essential Knowledge and experience
- At least 3 years’ experience of an operational engineering role within the pharmaceutical industry
- Root Cause investigation experience and implementation of CAPA’s
- GMP quality management system experience particularly focussed on Non Conformance, change controls, CAPA management, deviations and management of documents
- At least 3 years’ experience of carrying out internal audits and hosting external and regulatory audits
Desirable knowledge and experience
- Application of process improvement or lean manufacturing tools and methodologies such as Six Sigma
- Knowledge of Aseptic or Biopharmaceutical GMP Manufacturing processes
Harris Lord is acting as a recruitment agent for this role.
Contact: Adrian Hole
Keywords: SQA Engineer, QA Engineer, Quality, CAPA, FDA, Change Control, Food And Drug Agency, Compliance, Deviations, GLP, GMP, GxP, QA, Quality, MHRA
Apply For This Job