CSV Consultant

Walker Cole International is supporting a UK-based life sciences organisation in the appointment of a CSV Consultant (Contract). This role will support the implementation and validation of eQMS and other GxP computerised systems within a highly regulated environment, ensuring compliance with global regulatory requirements and maintaining inspection readiness. This position will play a key role in strengthening the organisation’s Quality Management System (QMS), ensuring data integrity and supporting cross-functional teams across Quality, IT and Operations. The successful candidate will provide hands-on Computer System Validation expertise across system lifecycle activities and regulatory compliance.

Key Responsibilities

• Support implementation and validation of eQMS and GxP computerised systems
• Provide CSV expertise aligned with EU GMP, MHRA data integrity guidance and FDA 21 CFR Part 11 / 210 / 211
• Prepare and review validation lifecycle documentation (URS, risk assessments, IQ/OQ/PQ, traceability, reports)
• Ensure data integrity compliance in line with ALCOA+ principles
• Support change control, deviations and risk management for computerised systems
• Provide guidance on Annex 11 and Part 11 compliance
• Contribute to SOPs, procedures and training materials
• Support regulatory inspections and internal audits
• Collaborate with cross-functional teams to maintain inspection readiness

Required Experience and Skills

• Proven Computer System Validation experience in GxP environments
• Strong knowledge of EU GMP, MHRA data integrity guidance and FDA 21 CFR Part 11 / 210 / 211
• Experience preparing validation documentation and supporting inspections
• Strong stakeholder engagement and communication skills
• Ability to operate in a hands-on onsite contract role

Working Pattern

On-site (UK)

Contract Length

6 months

Rate

Day rate negotiable depending on experience

Location

United Kingdom

Keywords

CSV | Computer System Validation | Annex 11 | 21 CFR Part 11 | Data Integrity | GMP | Contract | Life Sciences