CSV Analyst – GxP Validation & Compliance

Norgine; Hengoed; On-site; GBP 45,000 - 65,000; Full time

Job summary

Norgine is hiring a Computer Systems Validation Analyst in the United Kingdom to ensure IT Quality Management and validation documentation meet GxP regulatory requirements. You will support the ongoing development of the Global IT validation strategy and approach.

This is a 12-month fixed-term contract. You will engage in CSV governance, risk-based validation, and cross-functional collaboration with Quality, IT and project teams to define validation requirements and maintain validated systems.

Qualifications

• Demonstrable experience in Computer Systems Validation within a GxP-regulated environment.
• Good understanding of business requirements, high-level solutions and IT infrastructure alongside CSV experience.
• Strong understanding of regulatory requirements, including EudraLex Annex 11 and FDA 21 CFR Part 11.
• Good understanding of data integrity requirements within regulated environments.
• Experience developing, reviewing and maintaining validation documentation and records.
• Experience with risk-based validation, quality systems, change management and compliance risk management.
• Knowledge of quality assurance methodologies, requirements creation and verification, review and reporting, and data management techniques.
• Ability to work collaboratively across Quality, IT, business and project teams, providing guidance and SME input.
• Familiarity with ERP/BI, LIMS and HRIS would be beneficial.

Responsibilities

• Execute and support risk-based CSV activities through the lifecycle of GxP systems.
• Develop, review and maintain validation documentation to keep systems validated.
• Support validation governance, planning, and Validation Master Plan maintenance.
• Coordinate validation testing, document outcomes and address issues and risks.
• Collaborate with Business, Quality, IT and project teams to define validation requirements.
• Support internal audits, regulatory inspections, periodic reviews and compliance assessments.
• Provide guidance on CSV, data integrity and regulatory requirements and improve CSV frameworks.

Skills

CSV in GxP

Regulatory compliance

Data integrity

Documentation

Risk-based validation

Quality systems

Change management

Cross-functional collaboration

ERP/BI/LIMS/HRIS familiarity

Tools

ERP/BI

LIMS

HRIS

Job description

Norgine is hiring a Computer Systems Validation Analyst in the United Kingdom to ensure IT Quality Management and validation documentation meet GxP regulatory requirements. You will support the ongoing development of the Global IT validation strategy and approach.

This is a 12-month fixed-term contract. You will engage in CSV governance, risk-based validation, and cross-functional collaboration with Quality, IT and project teams to define validation requirements and maintain validated systems.