Senior IT Quality & CSV Specialist

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.

• 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.

AMS is a global workforce solutions partner committed to creating inclusive, dynamic, and future-ready workplaces. We help organisations adapt, grow, and thrive in an ever-evolving world by building, shaping, and optimising diverse talent strategies.

We partner with PwC to support their contingent recruitment processes. Acting as an extension of their recruitment teams, we connect them with skilled interim and temporary professionals, fostering workplaces where everyone can contribute and succeed.

PwC is a hugely diverse business, bound by our global purpose - to build trust in society and solve important problems. Our greatest opportunity to deliver our purpose is through meaningful work that makes a difference to our clients and society. We have a culture of high performance built on exceptional quality, ethical and professional standards. We lead by example. Our standards for quality - and care - are high. And together we surpass them. We believe we can make the biggest impact when leading with our purpose, values and PwC Professional behaviours in every interaction., AMS, a Recruitment Process Outsourcing Company, may in the delivery of some of its services be deemed to operate as an Employment Agency or an Employment Business