An opportunity has arisen for a Senior QA Officer to join the Quality Assurance team. The role will be responsible for the development, improvement and maintenance of the Quality Management System (QMS).
The role will include but not be limited to the following:
- Handling Dermal quality-related customer complaints in conjunction with PVG and other departments as required.
- Leading and performing internal audits across a variety of GxP areas.
- Initiating and coordinating non-conformance reports and/or CAPAs.
- Acting as the administrator of eQMS.
- Preparing and presenting training material in QMS processes.
- Coordinating, monitoring and preparing KPI reports on the Dermal Quality System.
- Contributing to continuous improvement of QMS in line with overall improvement and harmonisation of the Diomed Group QMS.
- Support QA activities at other Dermal sites i.e. validation activity, project support
may result in up to 5 days/month working at other sites.
- Planning, managing and delivering projects to meet the demands of the business.
- Organising and coordinating activities for regulatory inspections.
- Experience working in QA and technical roles within a Pharmaceutical/Medical
Device environment along with a degree or equivalent in a relevant scientific
- Clear understanding of; GMP, or any other GxP area, regulatory and accreditation systems and quality management.
- Understanding or experience of all types of validation i.e. Process, Equipment,
Cleaning and computer systems.
- Good understanding of process approach and competent in process mapping.
- Ability to take decisions, to analyse information and prepare coherent
- Competent in computer packages, Microsoft Office, and electronic quality
management package (preferred) and advanced excel skills to be able to create
pivot tables, design databases and dashboards.
- Competence in preparing presentations, delivering training to a variety of internal audiences.
- Ability to plan, organise and manage multiple projects.
- Emotionally resilient with the ability to work under pressure with a can-do attitude.
- Effective communicator with the ability to build strong working relationships.