Quality Officer - TCAT - 202121

About the Organisation: 

National Services Scotland (NSS) is a national NHS Board operating right at the heart of NHSScotland providing invaluable support and advice at a strategic and operational level.  NSS supports customers to deliver their services more efficiently and effectively and we offer shared services on a national scale using best-in-class systems and standards. Our priority is always the same to improve the health and well-being of the people of Scotland. We do this by working in partnership with colleagues across Health and Social Care to deliver fit for purpose solutions and systems, delivering high quality services that help our stakeholders to free up resources so they can be re-invested into essential services.  

The Post: 

The core purpose of the Scottish National Blood Transfusion Service is to meet the transfusion needs of patients in Scotland.  In support of this, we are committed to a range of programmes that will enhance the service provided to NHS Scotland in both clinical and operational areas.  

The candidate would be a member of the developing TCAT (Tissues, Cells and Advanced Therapeutics) QA team, which provides Quality support in a specialised area of the SNBTS team across JCC, Institute for Repair and Regeneration (IRR North formerly known as the Scottish Centre for Regenerative Medicine (SCRM)) and The Product Testing Unit (PTU) at the Bush. The team are responsible for the Quality support of SNBTS tech transfer for Clinical Trials to GMP stages of production and on to patient issue under the licensure of the organisation. This includes both IMPs and ATIMPs. The post also supports areas of iPSC, MSC and fertility cell banking, CAR-T, HPC stem cell processing, Islet and Cadaveric programmes which are performed on both sites, as well as support to the PTU area performing testing for environmental monitoring sampling, sterility testing and contract testing. Many of these services are performed at the SNBTS Headquarters at JCC where various licensure has been sought around the products manufactured in the clean room suite, future Isolator technology and current facilities critical for aseptic manufacturing.

These challenging and rewarding management posts would require utilising proficient knowledge in Quality Management Systems and learning, where relevant to support this specialised and developing area of SNBTS, providing routine Quality support to the team and projects. There are various QA product release processes for the services provided to assure compliance with the current principles of EU Good Manufacturing Practice, best practice, and ICH consistently across the board central to this.

The Candidate:

Applications are invited from professionals who have significant experience in the operation of a/SNBTS Quality Management System in a blood or pharmaceutical environment, or similar. Educated to Honours Degree level or equivalent, potentially holding a post graduate professional qualification e.g. MSc. Demonstrable experience of risk management, change management, Corrective and Preventative action planning, root cause analysis and Quality auditing are essential requirements for this role. Proven experience in Lean methodology and process development along with Quality agreements and supply chain visibility/management would be an advantage with the successful applicant being required to show evidence of being able to be a team member in an effective workforce.

An awareness and understanding of the MHRA/HTA/HFEA regulatory bodies, JACIE, ISO and associated Regulations, Directives and accreditation standards would also be advantageous. 

The post holder will report directly to the TCAT QA Manager supporting them in the delivery of SNBTS strategic plans. There is an expectation that the post holders will frequently travel to the NHS Centres noted above and between all SNBTS sites in support of this role.

The successful candidate will be required to undergo a Disclosure Scotland check. Any candidate who have lived/worked overseas for more than 12 months in the preceding 5 years will also be required to provide a criminal record check from the appropriate overseas agency.

Location and Working Pattern:

This post will be based at Jack Copland Centre, Edinburgh.

The work pattern is Monday to Friday, 37 hours per week.

It is a condition of this employment that you must live and remain a resident within the UK for the post in which you will be employed with NSS.

Benefits: 

Our benefits package includes pension scheme, comprehensive range of work life balance policies, occupational health services, learning resource centres and discounted leisure, financial and shopping benefits. HR Benefits Brochure.

Further information:

For an informal discussion on the post, please contact Kirsty Cheal, Quality Lead, Tissues, Cells and Advanced Therapeutics on .

Closing date for completed applications is Wednesday 4th December 2024.

Interviews will be held week commencing 16th December 2024.

Further information on NSS is available from: https://www.nss.nhs.scot/ 

Please note that the majority of correspondence is sent by e-mail only, so please check your e-mail regularly (including junk folders).

NHS National Services Scotland is an equal opportunities employer and as committed participant in the disability confident scheme, guarantees to interview all disabled applicants who meet the minimum criteria for our vacancies.