Description:
As youd expect, our quality management and compliance systems are crucial to our success. Youll be their champion: keeping licenses up to date, helping teams follow guidelines, recording and reporting on evidence, and managing audits. Anything and everything that keeps us working in the most efficient and safest way. Therell be some time behind a desk; but this is really a people-centric role. Well expect you to meet teams, government agencies and regulators, develop tailored solutions and respond to any incidents. A background in pharmaceutical or medical quality management would be advantageous and, ideally, a relevant post-graduate qualification (or equivalent). Its important youre also a consummate professional who can build strong relationships and ask the right questions while keeping an objective view of the work.
Main duties of the job
- Working with the Quality Assurance Managers and Quality Project Specialists to maintain compliance with all relevant licensing and accreditation standards for the plasma programme and improve service delivery to customers by working in partnership with all stakeholders.
- Developing subject matter expertise in specific plasma processes and deliver training of these processes to the wider Quality Directorate.
- Deputising for the Quality Project Specialists and assist Lead Quality Specialists and the Head of Quality Assurance & Regulatory Affairs when required.
- Day to day involvement with colleagues of varying levels of seniority in many departments and centres regarding all elements of the Quality system including adverse events, audit non-conformities, change control & validation, concessionary issue and recalls.
- Developing relationships with external organisations and ensuring that any external requirements are incorporated safely into the Quality system.
- Producing reports and leading quality review meetings with department managers as well as facilitating meetings to investigate adverse events to their root cause and identify effective actions to prevent re-occurrence
- Participating in Operational Improvement events using LEAN principles and projects or workshops to identify areas for and methods to improve the services we provide
About You
Experience and Knowledge
- Extensive experience of working in a regulated environment e.g. Pharmaceutical Manufacturing, NHSBT or equivalent.
- Experience of quality audit and use of Quality Management Systems
- Understanding of relevant UK legislation and guidelines, e.g. Good Manufacturing Practice, Good Practice Guidelines for Blood Transfusion, ISO15189, General Data Protection Regulations and Freedom of Information; and any other appropriate statutory guidelines
- Experience of working with information technology using Microsoft Office packages (Word, Excel and PowerPoint), or equivalent Systems