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# Senior IT Quality & CSV Specialist

- **Company:** AMS CWS
- **Location:** London, UK (Remote available)
- **Experience:** Expert
- **Contract:** Temporary contract
- **Skills:** Data Integrity, Data Migration, Electronic Signatures, Systems Development Life Cycle, Software Engineering, System Testing, Test Scripts, Computerised Systems, Information Technology, GXP
- **Published:** September 4, 2026
- **Apply:** https://www.totaljobs.com/job/it-quality-specialist/ams-cws-job107934269

## About the Role

* Extensive experience in Technology Quality, IT Quality, Computer System Validation (CSV), or a related pharmaceutical quality role.
 * Advanced knowledge of Computer System Validation, Software Development Lifecycle (SDLC), Global GxP regulations, 21 CFR Part 11, Electronic Records and Signatures, Data Integrity requirements, and Quality Management Systems.
 * Practical experience reviewing the complete validation lifecycle, including requirements, traceability, design, testing, defects, validation reporting, and data migration.
 * Experience managing GxP risks, change controls, deviations, and CAPAs associated with electronic systems.
 * Experience supporting or leading GxP IT system or process audits with successful inspection outcomes.
 * Strong stakeholder management, communication, facilitation, and influencing skills, with experience working across global IT, Quality, and business functions.

At PwC we want every individual to feel valued, respected and empowered to contribute fully. Creating an environment where everyone belongs and thrives unlocks greater innovation, productivity and deeper engagement.

## Description

As Senior IT Quality & CSV Specialist you will provide independent quality and validation oversight for GxP computerised systems and complex global IT projects within a pharmaceutical environment.

You will work with project teams, system owners, IT teams and regulated business functions to ensure computer system validation activities are risk-based, compliant with global regulatory requirements, and inspection-ready.

What you'll do:

 * Provide quality oversight of GxP computerised systems throughout the full validation lifecycle.
 * Review validation documentation including Validation Plans, Validation Reports, requirements, traceability matrices, design documentation, test plans, test reports, testing records, defects, and data migration documentation.
 * Identify, document and escalate GxP compliance risks and support appropriate risk mitigation, deviations and CAPAs.
 * Provide QA oversight of change controls for GxP electronic systems, ensuring changes are appropriately assessed, documented, approved and validated.
 * Interpret and apply regulatory requirements relating to Computer System Validation, Data Integrity, Electronic Records and Electronic Signatures, including 21 CFR Part 11.
 * Support regulatory inspections, third-party inspections and internal audits while ensuring systems and documentation remain inspection-ready.


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