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As a vital part of NHS Scotland, NHS National Services Scotland’s mission is to enable and support the delivery of better health and better care, working in partnership. We do this by providing a range of specialised support services that enable NHS Boards to focus their efforts on delivering health improvement and patient care.
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 QA team which provides Quality support in a specialised area of the SNBTS team across JCC, Scottish Centre for Regenerative Medicine (SCRM) and The Product Testing Unit (PTU) at the Bush. The team are responsible for the Quality support of 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 ATMPs. The post also supports areas of iPSC, MSC and fertility cell banking, 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. We are also currently transferring many of these functions and services to the SNBTS Headquarters at JCC and finalising commissioning of the clean room suite, Isolator technology and facilities critical for aseptic manufacturing.
This challenging and rewarding management post 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 & projects. There are various QA product release processes for the services provided to assure and compliance with the current principles of EU Good Manufacturing Practice, best practice and ICH consistently across the board central to this.
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 and associated Regulations, Directives and standards would also be advantageous.
The post holder will report directly to the Quality Assurance Lead for Tissues, Cells & Advanced Therapeutics supporting them in the delivery of SNBTS strategic plans. There is an expectation that the post holder will frequently travel to the NHS Centres noted above and between all SNBTS sites in support of this role.
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.
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.
For an informal discussion on the post, please contact Andrew Ruck, Quality Lead, Advanced Therapeutics, Tissues and Cells on 0131 314 5722 or 07973 663 914 or Evelyn McLennan, Associate Director on 0131 314 5702
Further information on NSS is available from: www.nhsnss.org
Closing date for completed applications is Friday 2nd August.
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