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...

Now who was supposed to sign this? E-signature tracking [✓].

Document Compliance – “Electronic Signature approval” – a key member of a global team that launched a “New Business Objects reporting Tool” for in-depth tracking of global documentation and capturing the electronic signatures which is a 21 CFR art 11 requirement. I helped launch the initiative by writing the business case objectives and financial benefits breakdown.– GE...

Lead a team of 16 people to manage over 50,000 documents.

Successfully lead a global QMS group, a documentation management team of 16 people, to own and manage the control of the “Global Compliance Documentation” a validated documentation repository / management system. An award of achievement was received for the effective management of global staff for documentation control – GE...