- Assistance with running the Quality Management System (QMS)
- Assistance with management of health and safety provisions
- Activities related to the Human Tissue Management System (HTMS)
- Helping to develop the Management System so that it is compliant with the requirements of statutory bodies such as the HSE, HTA and MHRA
- Assistance with preparations for external audit by competent authorities and notified bodies to maintain licences and certifications
- Managing the archiving of paper records relating to the QMS
- Assistance with the collection of data for monitoring key performance indicators in the business which will be reported to management review every 6 months
- Assistance with the investigation of the root causes of incidents or issues that arise within the business
- Assistance with maintenance of the Improvements Database and chasing up of corrective actions to drive continual improvement within the company
- Working with the Quality Manager to achieve quality objectives set by the senior management team
- Issuance and indexing of batch records for manufacturing and quality control activities
- Maintenance of the company intranet
The successful candidates will have the following responsibilities and training will be provided:
- Assistance with running the Quality Management System including Health & Safety management and Human Tissue management.
- Maintenance of management system compliance with the requirements of statutory bodies.
- Assistance with preparations for external audits by competent authorities and notified bodies such as the HSE, HTA, BSI, and MHRA.
- Performance of internal audits (training will be provided).
- Managing and archiving of paper and electronic records relating to the QMS.
- Collection and analysis of data for management review.
- Investigation of root causes of incidents or issues that arise within the business.
- Working with the Quality Manager to achieve quality objectives set by the senior management team.
- Maintenance of the QMS via the company intranet.
Skills & Experience:
- BSc in a life sciences or relevant experience
- Experience in quality management
- Knowledge of medical devices, ISO requirements, compliance, CAPA or auditing would be advantageous
- Good communication skills and computer literacy
- Attention to detail
- Team player
- Prior experience in a genetics/molecular biology laboratory would be advantageous
- Previous experience of working in a laboratory environment
- Strong written and verbal communication skills
- Good knowledge of Microsoft Office including Visio and Access
- Experience of working in a quality assurance or health & safety management role