- Monitoring and upholding Current Good Manufacturing Practices (cGMP) requirement to the manufacturing process in line with the recommendations for medical devices.
- To ensure implementation of, and adherence to, GMP throughout the company.
- The records of product batch release and Device History Records.
- The release of finished goods.
- The product bioburden and sterility requirement.
- Coordinating new/ revised packaging materials/ components/ label approval process, ensuring the process complies to the change control requirement.
- Review and approve qualification/ validation protocols and qualification/validation reports for tools, equipment, facilities, utilities, test methods and computerised systems.
- Evaluate local quality-related suppliers, monitor the supplier performance and provide feedback to the Quality Manager.
- Administrating quality audit activities to ensure compliance with procedure.
- Review Device History Record for Medical Devices and components manufactured by Owen Mumford.
- Coordinating microbiological monitoring of the environmental and products. As well as trending of the results.
- Performing continuous Quality Control evaluation and trend analysis on product quality issues, resolve quality problems and initiate corrective action with local SME as required.
- Working with SME’s to assist investigation and close out of any Exceptions and related Investigations and Corrective and Preventive Actions (CAPAs).
- Reporting to Quality Manager on progress with activities, provision of metrics and other information (e.g. input to Weekly /Monthly Quality Reports and Management Review Meeting) and escalation of issues.
- Complying with Owen Mumford policies and procedures and fulfil roles and responsibilities as defined to support full compliance.
- Identifying areas for improvement in daily work.
- Completing work to agreed priorities and meet due dates. Report to those in authority if any timelines are likely to be missed.
- Listening to performance feedback provided and take any necessary improvement action.
- Completing personal Training and Development Plan and seek opportunities to grow and learn.
- To be appointed as an Internal Quality Auditor upon qualified.