
Validation Technical Lead
On site
Talbot Green, United Kingdom
Full Time
11-04-2025
Job Specifications
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 downloadedhere. (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 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 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.
Person Specification
Skills And Attributes Essential
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
Qualifications Essential
Good Honours Degree in a Relevant discipline
Educated to MSc level or equivalent experience.
Knowledge Essential
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
Desirable
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
Experience Essential
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
Desirable
Software development Analysis & Programming
Experience of CSV of Cloud Hosted systems
NHS Informatics
Training experience
Other Essential
Ability to be flexible in hours worked in accordance with exigencies of the service.
Ability to travel occasionally outside of the UK when required
Desirable
Welsh Speaker (Level 1) or willingness to work towards
Person Specification Skills and Attributes Essential
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...
About the Company
If giving is in your blood, please help. The Welsh Blood Service organises the collection, testing, processing and distribution of blood and blood products. We rely entirely on voluntary donors to maintain supplies to Welsh hospitals. Know more
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