Rewriting a QMS & Training the Business.

QMS Documentation Re-structure – Key player with the effective handling and planning of documentation re-writing following a company re-structuring. This required control / management of existing business documents through the phase of the re-structure – An award of achievement was received for the effective handling and launch of the QMS documentation during its rewrite due to a company restructure – GE...

Managing 300 Documents in Paper? Let’s go digital!

To progress from a “Manual Documentation Control System” to a custom developed “Digital Document & Tracking System”, which incorporated a document progress reminder & report review status for 300+ compliance SOPs using MS Excel & Pivot Tables, etc.. – (Hammersmith Hospital) – GE...

Inspection Readiness in 5 days.

Improved Hammersmith Hospital’s Imanet Projects site inspection readiness from 8 months to 1 weeks notice, plus guided through two external auditor inspections with little to no CAPA resolutions needed – GE Healthcare.

FDA Site Inspection Pass.

After travelling to be the onsite QA representative during a thorough 3 month pre-FDA inspection at Buc, near Paris in France, their office site passed and no significant issues were raised and they passed with no FDA CFR citations – GE Healthcare