GxP IT Validation Analyst (CSV)

Norgine B.V.; Cefn Hengoed; On-site; GBP 70,000 - 90,000; Full time

Job summary

Norgine B.V. in the United Kingdom seeks an IT Quality compliance professional to own CSV governance and ensure GxP systems meet regulatory requirements. You will drive validation strategy and collaborate with IT, Quality and business teams to sustain validated states.

You will coordinate testing, support audits, and contribute to continuous improvement of CSV frameworks and processes while delivering tangible patient impact.

Qualifications

• Experience in Computer Systems Validation (CSV) within a GxP-regulated environment.
• Strong understanding of regulatory requirements, including data integrity concepts.
• Ability to develop, review and maintain validation documentation and records.
• Experience with risk-based validation and change management.

Responsibilities

• Execute and support risk-based CSV activities across the lifecycle of GxP systems, from implementation to retirement.
• Develop, review and maintain validation documentation to keep systems validated.
• Support validation governance, including Validation Master Plan maintenance, change assessments and standards.
• Coordinate validation testing, document outcomes, and support risk/issue resolution.

Skills

CSV

GxP

Regulatory requirements

Data integrity

Validation documentation

Quality systems

Audits

Cross-functional collaboration

Tools

ERP/BI

LIMS

HRIS

Job description

Norgine B.V. in the United Kingdom seeks an IT Quality compliance professional to own CSV governance and ensure GxP systems meet regulatory requirements. You will drive validation strategy and collaborate with IT, Quality and business teams to sustain validated states.

You will coordinate testing, support audits, and contribute to continuous improvement of CSV frameworks and processes while delivering tangible patient impact.