Validation Analyst

Welsh Blood Service; Pontyclun; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading healthcare organization in Pontyclun is seeking a Validation Analyst to manage Computer Systems Validation processes for Cloud-based systems. The ideal candidate has analytical experience and excellent communication skills, can work independently, and contributes to compliance in a GxP environment. This role offers a chance to be part of a dynamic team that focuses on improving healthcare services across Wales.

Qualifications

• Experience in a GxP critical environment.
• The ability to speak Welsh is desirable.

Responsibilities

• Contribute towards MHRA compliance for Validated Systems.
• Implement WBS Validation Policies and SOPs.
• Assist in producing Validation deliverables.
• Participate in Qualification execution.
• Ensure deliverables follow GAMP guidelines.

Skills

Analytical experience

Excellent communication skills

Ability to work under strict deadlines

Proactive and independent work

Job description

Overview

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.

Responsibilities

• The Validation Analyst will be responsible for contributing towards the achievement of MHRA compliance for Validated Systems throughout the WBS (a GxP critical environment) through:
• Implementing, and adhering 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.

Qualifications

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

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.