NHS
Validation Technical Lead
This job is now closed
Job Description
- Req#: C9063-25-0025?language=en&page=803&sort=publicationDateDesc
- General management
- Ability to work autonomously and proactively
- Excellent analytical and interpretive skills
- Change management skills
- Technical awareness and writing skills
- Ability to prioritise effectively and deliver to deadlines
- Commitment to providing quality software solutions
- Ability to communicate effectively with people at all levels both Nationally & across the UK
- Ability to collaborate in a team
- User focussed
- Ability to respect and value the diversity of all people
- Good Honours Degree in a Relevant discipline
- Educated to MSc level or equivalent experience.
- Highly developed knowledge of CSV management and current best practice.
- GAMP methodology requirements
- Demonstrable understanding and experiential knowledge of NHS regulation and compliance and quality drivers.
- Evidence of ongoing personal development
- Digital Systems Standards
- A relevant training qualification
- Knowledge of Blood Establishment function.
- Specialist knowledge of regulatory frameworks. These will include Medicines and Healthcare products Regulatory Agency (MHRA), Blood Safety and Quality Regulations (BSQR), UK guidelines (Red Book) and ISO standards as appropriate.
- Knowledge of QMS inc. change control, CAPA & incident reporting.
- Knowledge of GDPR, Information Governance and Records Management
- Substantial experience of Service or systems management in a regulated healthcare setting
- Specialist information analysis and reporting skills
- Significant experience of working in a GMP environment or similar quality environment
- Extensive experience of Project management or Agile methodologies.
- Experience of working in a customer focused environment
- Performance to deadlines
- Software development Analysis & Programming
- Experience of CSV of Cloud Hosted systems
- NHS Informatics
- Training experience
- Ability to be flexible in hours worked in accordance with exigencies of the service.
- Ability to travel occasionally outside of the UK when required
- Welsh Speaker (Level 1) or willingness to work towards
- General management
- Ability to work autonomously and proactively
- Excellent analytical and interpretive skills
- Change management skills
- Technical awareness and writing skills
- Ability to prioritise effectively and deliver to deadlines
- Commitment to providing quality software solutions
- Ability to communicate effectively with people at all levels both Nationally & across the UK
- Ability to collaborate in a team
- User focussed
- Ability to respect and value the diversity of all people
- Good Honours Degree in a Relevant discipline
- Educated to MSc level or equivalent experience.
- Highly developed knowledge of CSV management and current best practice.
- GAMP methodology requirements
- Demonstrable understanding and experiential knowledge of NHS regulation and compliance and quality drivers.
- Evidence of ongoing personal development
- Digital Systems Standards
- A relevant training qualification
- Knowledge of Blood Establishment function.
- Specialist knowledge of regulatory frameworks. These will include Medicines and Healthcare products Regulatory Agency (MHRA), Blood Safety and Quality Regulations (BSQR), UK guidelines (Red Book) and ISO standards as appropriate.
- Knowledge of QMS inc. change control, CAPA & incident reporting.
- Knowledge of GDPR, Information Governance and Records Management
- Substantial experience of Service or systems management in a regulated healthcare setting
- Specialist information analysis and reporting skills
- Significant experience of working in a GMP environment or similar quality environment
- Extensive experience of Project management or Agile methodologies.
- Experience of working in a customer focused environment
- Performance to deadlines
- Software development Analysis & Programming
- Experience of CSV of Cloud Hosted systems
- NHS Informatics
- Training experience
- Ability to be flexible in hours worked in accordance with exigencies of the service.
- Ability to travel occasionally outside of the UK when required
- Welsh Speaker (Level 1) or willingness to work towards
Job summary
An exciting opportunity has arisen for an enthusiastic, self-motivated, and committed individual to join our Quality Assurance team as Validation Technical Lead within the Welsh Blood Service (WBS).
Working for the WBS can be an incredibly rewarding experience for several reasons, both personal and professional, providing a supportive environment, a sense of purpose and allowing you to make a difference in people's lives.
The position of Validation Technical Lead is offered on a fixed term/ secondment basis to collaboratively support and manage the Computer Systems Validation (CSV) processes for Cloud-based systems associated with the implementation of a replacement Blood Establishment Computer System (BECS) in accordance with regulatory requirements, supporting the WBS 5-year strategy programme.The ideal candidate must have highly developed knowledge of CSV management of cloud-based systems and current best practice, including analytical experience, excellent leadership and communication skills and significant experience of working in a GMP or similar quality environment.
For an informal conversation about the role please contact Laurie Thomas, Head of Validation & Risk Management - Laurie.Thomas@wales.nhs.uk
Main duties of the job
The Validation Technical Lead will be responsible for establishing, in accordance with the WBS Quality Management System, that the organisations computerised systems are effective, efficient and compliant with regulatory and best practice standards and regulations. This is achieved through:
- the provision of expert advice
- the application of specialist knowledge
- collaboration with senior leaders and operational areas within the WBS, and appropriate external organisations to embed quality throughout the software development lifecycle
The Validation Technical Lead will work with the Head of Validation & Risk Management and WBS Senior Leadership team along with other colleagues to ensure compliance of the BECS and other computerised systems to business objectives, quality risk management expectations whilst ensuring Good Practice principles are maintained throughout the work programme.
This post is fixed term/secondment until 31/03/2026. If you are interested in applying for the secondment position, you must obtain permission from your current line manager prior to applying for this post.
PLEASE NOTE Applicants will need to get permission from their line manager before submitting their interest, a release form to be included with your application form can be downloaded here . (This form is for the staff member and line manager to complete and return to you)
About us
Here at Velindre University NHS Trust we are extremely proud of the specialist services we provide across the whole of Wales in our cutting-edge Velindre Cancer Centre and ouraward-winning Welsh Blood Service, as well as the expertise of our corporate functions that bring the two divisions together. We are also fortunate to host the NHS Wales Shared Services Partnership and Health Technology Wales and have developed strong partnership working with these expert services.
Formed in 1999, the Trust has a dedicated workforce that continuously strives to apply the key principles of value based healthcare through a wide array of roles. We play a vital role in the communities we support and have ambitious plans for the future to continue to improve the services we deliver. We strive to maintain our core values in everything we do by being; accountable, bold, caring and dynamic, and ensuring the best possible care for our patients and donors.
If you want to work for an organisation that prides itself on making a real difference and offers exciting career opportunities then Velindre University NHS Trust is the place for you.
Visit our website to find out more https://velindre.nhs.wales/
Date posted
08 April 2025
Pay scheme
Agenda for change
Band
Band 7
Salary
£46,840 to £53,602 a year per annum
Contract
Fixed term
Duration
12 months
Working pattern
Full-time
Reference number
120-AC003-0225-A
Job locations
Welsh Blood Service
Ely Valley Road
Talbot Green, Pontyclun
CF72 9WB
Job descriptionJob description
Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.
Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.
Person SpecificationPerson Specification
Skills and Attributes
Essential
Qualifications
Essential
Knowledge
Essential
Desirable
Experience
Essential
Desirable
Other
Essential
Desirable
Skills and Attributes
Essential
Qualifications
Essential
Knowledge
Essential
Desirable
Experience
Essential
Desirable
Other
Essential
Desirable
Additional informationDisclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
Welsh Blood Service
Address
Welsh Blood Service
Ely Valley Road
Talbot Green, Pontyclun
CF72 9WB
Employer's website
Employer details
Employer name
Welsh Blood Service
Address
Welsh Blood Service
Ely Valley Road
Talbot Green, Pontyclun
CF72 9WB
Employer's website
About the company
National Health Service (NHS) is the umbrella term for the publicly-funded healthcare systems of the United Kingdom (UK). The founding principles were that services should be comprehensive, universal and free at the point of delivery—a health service based on clinical need, not ability to pay. Each service provides a comprehensive range of health services, free at the point of use for people ordinarily resident in the United Kingdom apart from dental treatment and optical care.