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Walker Cole International is currently partnered with a Pharmaceutical company. To support ongoing validation activities, we are searching for a CSV Consultant based remotely in the UK for an initial 3-month contract.
The ideal candidate will have the following responsibilities:
Computer System Validation
Lead and execute CSV activities across GxP systems, including validation planning, risk assessments, protocol development (IQ/OQ/PQ), testing, traceability, and final validation reporting in line with GAMP 5 principles.
Compliance & Quality Assurance
Ensure validated computerised systems remain compliant with MHRA, EU GMP, FDA 21 CFR Part 11, Annex 11, and internal quality requirements while supporting periodic reviews and audit readiness.
System Lifecycle & Change Management
Support the validation of new and existing GxP systems through change controls, system upgrades, deviations, CAPAs, and retirement activities, ensuring documentation remains inspection-ready throughout the system lifecycle.
Cross-Functional Collaboration
Work closely with Quality Assurance, IT, Engineering, Manufacturing, and system owners to deliver validation activities, provide technical guidance, and support business-critical digital transformation projects.
Contract details:
Start date: ASAP
2–3 days per week
£400–500 per day - inside OR outside IR35
Duration of project: 3 months (with potential extension)
Location: Remote, United Kingdom
Computer System Validation | CSV | Validation Consultant | GAMP 5 | Annex 11 | 21 CFR Part 11 | GxP | GMP | Quality Assurance | Validation | Computerised Systems | Change Control | CAPA | Pharmaceutical | Biotechnology | Contract | Contractor | Remote | UK