GxP Recruitment invites applications on behalf of our client based in Lanarkshire where an excellent new opportunity has arisen for a GMP Quality Systems Manager to join their team on a permanent basis.
The post holder will support the quality and operational departments to ensure operational excellence and to exercise overall responsibility for the Quality Systems.
Key duties include:
* Management of quality systems personnel
* Maintain and continually improve the quality management systems to ensure full compliance with the UK and EU regulations.
* Ensure risk management procedures are in place and risk assessments are performed across all aspects of GMP activities
* Ensure systems are in place and are followed for the reporting and investigation of quality related incidents, defective products or adverse events, these systems will identify the root cause of such incidents and generate strategies for preventative actions
* Ensure that equipment and processes used in the manufacture, storage and distribution of products are subject to effective validation and that documentation used in validations are approved.
* Ensure that effective change control procedures are in place for changes to the manufacturing process, GMP activities and other areas of the company as applicable.
* Manage the internal and external audit programme
* Generate quality metrics for quality systems to ensure key performance indicators measure progress against quality objectives
The ideal candidate:
* Degree in a relevant life science or equivalent qualification
* Significant experience in a similar role within GMP
* Previous supervisory or management experience is essential
* Experience in successful management of quality management systems
* Experience in using Q-Pulse electronic management system would be highly desirable
* Good understanding and knowledge of GMP cleanrooms operating at grade A/B level is desirable
* A good scientific knowledge of biological systems would be desirable
* Excellent written/oral communication and interpersonal skills