Computer System Validation Analyst at norgine-2

Location: Hengoed, Wales
Type: Full-time
Posted: Jul 17, 2026

Description

Norgine is seeking a CSV Analyst 12 Months - FTC to ensure compliance with IT Quality Management System, Validation documentation, and related processes/procedures/systems against applicable regulations. The role involves identifying and closing weaknesses, developing and approving CSV policies, supporting project teams in defining validation levels and creating validation packs, acting as a subject matter expert, reviewing changes to validated systems, assessing new systems for GxP impact, supporting formal testing, maintaining the Local Validation Master Plan, assisting in audits, interacting with management, implementing improvement opportunities, and staying updated on evolving regulatory requirements.

Required Skills

cGMP Regulations
Microsoft Office
ERP
BI
LIMS
HRIS

Additional Information

Required Previous Experiences: Experience in a validation and qualification of complex computer systems.
Preferred Qualifications: Thorough knowledge of cGMP regulations related to CSV.
Good written and oral communication skills.
Competent user of Microsoft Office.
Familiarity with multiple system types such as ERP and BI, LIMS, HRIS etc.
Good understanding of business requirements, high-level solutions and infrastructure components, combined with CSV system experience.
Wide experience of the various regulatory requirements relating to Eudralex Annexe 11, FDA CFR21 Part 11, etc..
Experience of the data integrity implications of the regulated environment.
Confident communicator, able to network effectively in a diverse business community.
Proactive, professional approach, undertakes tasks and responds to business requests in a positive and constructive manner.
Keeps industry and organization knowledge current in order to provide up to date solutions and be best placed to advise on future capabilities.