Quality and Compliance Manager
12 month contract
£554.21 Via approved UMB
My Client is looking for a Quality and Compliance Manager for a 12 month contract position based in Ulverston.
The Quality and Compliance manager will be responsible for ensuring adherence to external and GSK internal standards and continuous improvement of Quality systems in use at Ulverston, with responsibility for Compliance and Validation related activities including:
· Audits (L1 to L4)
· Quality councils
· QMS implementation
· CAPA management
· Change Control
· Quality metrics
· Record retention
· Quality Alerts
· Regulatory updates
· Validation projects
- Ensuring world class compliant quality systems through continuous improvement and keeping abreast of regulatory requirements for GMP, Oral manufacture and laboratory activities. Ensure best use is made of company experience and existing work through effective networking with other site staff and communicate key findings to other functions as required. Deliver training to support as appropriate.
- To support level 3 and 4 audits through supporting management of audits by support of the inspection readiness program.
- Support the delivery of the site level 2 audit program. Provide a mechanism for tracking the status of audit commitment.
- Ensuring alignment of site processes and documentation to the company QMS. CAPA, Change Control Quality Regulatory Intelligence, Record Retention, CDMS, quality alerts and bulletins.
- Undertake Level 1 audits in accordance with the schedule.
- Supporting operation and improvement of quality councils to ensure the Ulverston QMS is compliant, in use and effective. Generation of quality metrics to show status of site compliance to standards and quality objectives.
- To provide information to functions on current regulatory and company standards that must be met to maintain compliance.
- Be the subject matter expert (SME) during inspections for CAPA, Change Control, Level 1 and 2 auditing and QMS.
- Awareness of the validation project requirements for the site covering both plant and the laboratories.
- Automation system validation (working to CSQMS) working in conjunction with site automation.
- IT system validation (working to iTMS) working in conjunction with IT (Tech)
- Equipment, facilities and utilities validation (working to Primary DSOPs or equivalent) and utilising the commissioning and qualification system (CQS) or equivalent working in conjunction with Engineering and Technical
- Performing periodic validation reviews (PVRs)
- Supporting the delivery of the Quality Improvement Plan
- Performing validation assessments for change controls (both equipment and software)
- Knowledge of corporate and regulatory compliance
- Knowledge of QMS Processes
- Minimum HNC or equivalent in an appropriate scientific subject
If you feel you would be suitable for the role of Quality and Compliance Manager, please apply with your most up to date CV