An exciting opportunity has arisen for an enthusiastic, self-motivated, and committed individual to join our Validation team as Validation Technical Lead within the Welsh Blood Service (WBS).
The position 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.
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:
1. the provision of expert advice
2. the application of specialist knowledge
3. 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.
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 our award-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 here.
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
* Good Honours Degree in a Relevant discipline
* Educated to MSc level or equivalent experience.
Knowledge
* Highly developed knowledge of CSV management and current best practice.
* Demonstrable understanding and experiential knowledge of NHS regulation and compliance and quality drivers.
* Evidence of ongoing personal development
* Digital Systems Standards
* 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
* 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
* Experience of CSV of Cloud Hosted systems
* NHS Informatics
* Training experience
Skills and Attributes
* General management
* Ability to work autonomously and proactively
* Excellent analytical and interpretive 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
* Ability to respect and value the diversity of all people
Other
* 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
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.
#J-18808-Ljbffr