Job summary An exciting opportunity has arisen for an enthusiastic, self-motivated, and committed individual to join our Validation team as Validation Lead within the Welsh Blood Service (WBS). The position is offered on a permanent basis to collaboratively lead and support the on-going compliance of Computer Systems Validation (CSV) processes for GxP critical computerised systems in accordance with regulatory requirements, supporting the WBS 5-year strategy programme. The ideal candidate must have highly developed knowledge of CSV management and current best practice, analytical experience, excellent leadership and communication skills and performance to strict deadlines. For an informal conversation about the role please contact Laurie Thomas, Head of Validation & Risk Management - Laurie.Thomaswales.nhs.uk The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply. Main duties of the job The Validation Lead will work collaboratively to support and manage the Computer Systems Validation (CSV) processes for GxP critical computerised systems within the Welsh Blood Service in accordance with regulatory requirements. The Validation 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: o the provision of expert advice o the application of specialist knowledge o collaboration with senior leaders and operational areas within the WBS, and appropriate external organisations to embed quality throughout the software development lifecycle. The Validation Lead will work with the Head of Validation & Risk Management and WBS Senior Leadership team along with other colleagues to ensure on-going compliance of GxP critical computerised systems including Blood Establishment Computer System (BECS), Laboratory Information Management System (LIMS) and other critical GxP systems and equipment, to business objectives, quality risk management expectations whilst ensuring Good Practice principles are maintained throughout associated work programmes. 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 14 January 2025 Pay scheme Agenda for change Band Band 7 Salary £46,840 to £53,602 a year per annum Contract Permanent Working pattern Full-time Reference number 120-AC002-0125 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 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 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 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 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 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 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 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). Additional information 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 https://www.welsh-blood.org.uk/ (Opens in a new tab)