Join the Welsh Blood Service as a Validation Analyst. An exciting opportunity has arisen for an enthusiastic, self-motivated, and committed individual to join our Quality Assurance team.
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.
Job Summary
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:
* 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.
Person Specification
Essential qualifications include a BSc (Hons) Relevant Degree or equivalent experience of process and software validation. Desirable knowledge includes knowledge of a Blood Establishment function, Knowledge of QMS including change control, CAPA & Incident Reporting, and Project Management.
* Essential experience includes experience of working within a Quality Management System and experience of working with GMP & GAMP methodologies.
* Desirable experience includes I.T. experience in an analytical role and/or significant experience within WBS at an appropriate level, Software development, Analysis & Programming.
Skills & Attributes: Essential skills include excellent analytical skills, computer literate with Microsoft Office, ability to communicate effectively both orally and in written format, ability to work independently 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, and ability to work on own initiative.
* Desirable skills include the ability to be flexible in hours worked in accordance with exigencies of the service, must be able to travel as required, and Welsh speaker (level 1) or willingness to work towards.
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.
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.
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