Will Willox

Quality Assurance Associate (Validation & Qualification) @4basebio

Cambridgeshire, GB

In my current role, I lead validation efforts across facilities, equipment, and computer systems in a GMP-regulated biotech environment. With a background in microbiology and prior experience in pharma and medtech QA, I bring a quality-focused, practical approach to delivering compliant and efficient validation solutions.• Lead validation for a remediation to Annex 1 GMP standard of a cleanroom facility and bespoke HVAC system, managing the full lifecycle from URS through PQ execution.• Manage large-scale equipment onboarding projects, ensuring timely qualification and operational readiness.• Execute CSV activities for instrumentation and software used across manufacturing, QC, and warehouse operations.• Develop, implement, and maintain validation documentation and risk-based procedures aligned with GMP standards.• Collaborate with external consultants and internal teams to plan, prioritize, and deliver validation milestones.• Contributed to securing an IMP license from the MHRA by helping mature the site’s QMS to regulatory standards.• Support ongoing quality operations including document control, investigations, change control, CAPA, and training.