Validation Analyst

NHS; Pontyclun; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading healthcare organization is looking for a Validation Analyst to join their Quality Assurance team. You will support the Computer Systems Validation processes and contribute to regulatory compliance. The ideal candidate will possess strong analytical skills, an understanding of quality management systems, and experience in a healthcare setting. Welsh language skills are desirable, and flexibility in hours and travel may be required. This is a fixed term position for 24 months.

Qualifications

• Experience of working within a Quality Management System.
• Experience with GMP & GAMP methodologies.
• I.T. experience in an analytical role or significant experience within WBS.

Responsibilities

• Contribute towards achievement of MHRA compliance.
• Assist in production of Validation deliverables.
• Ensure adherence to Good Automated Manufacturing Practice guidelines.

Skills

Analytical skills

Communication

Proactive working

Team collaboration

Organizational skills

Education

BSc (Hons) Relevant Degree or equivalent experience

Tools

Microsoft Office

Job description

An exciting opportunity has arisen for an enthusiastic, self-motivated, and committed individual to join our Quality Assurance team as Validation Analyst 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 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 analytical experience, excellent communication skills, experience of working to strict deadlines and the ability to work proactively, independently, actively contributing within a team environment.

For an informal conversation about the role please contact Laurie Thomas, Head of Validation & Risk Management - [e-mail]

Main duties of the job

The Validation Analyst will be responsible for contributing towards the achievement of Medicines and Healthcare products Regulatory Agency (MHRA) compliance for Validated Systems throughout the WBS (a GxP critical environment) through:

The implementation of, and adherence to, the WBS Validation Policies, Strategies and Standard Operating Procedures (SOPs).

Assisting in the production of Validation deliverables, including User Requirements Specifications, Validation Plans, Qualification Protocols, Test Scripts and Reports.

Participating in Qualification execution.

Ensuring all Validation deliverables are completed to Good Automated Manufacturing Practice (GAMP) guidelines and in accordance with Good Documentation Practice (GDP) and ALCOA++ principles.

Providing advice and support to project teams with regard to promoting validation best practice aligned to organisational requirements.

This post is fixed term/secondment for 24 months due to - meet the needs of the service

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.

The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply.

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 1994, 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/

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

• BSc (Hons) Relevant Degree or equivalent experience of process and software validation

Knowledge

• Knowledge of a Blood Establishment function
• Knowledge of QMS including change control, CAPA & Incident Reporting
• Project Management

Experience

• Experience of working within a Quality Management System
• Experence of working with GMP & GAMP methodologies
• I.T. experience in an analytical role and / or significant experience within WBS at an appropriate level

Skills & Attributes

• Excellent analytical skills
• Computer literate with Microsoft Office
• Ability to communicate effectively both orally and in written format
• Ability to work independantly and proactively
• Ability to organise own workload
• Ability to work as part of a team
• Ability to interact effectively with people at all levels
• Ability to work under pressure and to strict deadlines
• Ability to work to work on own initiative

Other

• Ability to be flexible in hours worked in accordance with exigencies of the service
• Must be able to travel as 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.