Responsible for Quality Training (1000+ new hires yearly, 1500+ training sessions yearly, 20 qualified trainers)

On a FDA-approved manufacturing facility, my main activities are to:- Prepare for inspections- Train personnel on cGMP- Ensure Functional Administration of Learning Management System, Electronic Batch Record Management System and Electronic Document Management System

My main activities at FAREVA Romainville were to:- Prepare a Final Approval Inspection by French National Agency for Medicines and Health Products Safety (ANSM).- Manage the transfer of the documentation system from Sanofi to FAREVA (about 600 documents).- Plan and check the update of documentation (SOP, Manufacturing Batch Record, Forms...).- Create procedures to organise the activity in compliance with the cGMP.- Set up an EDMS in order to have a better… Show more My main activities at FAREVA Romainville were to:- Prepare a Final Approval Inspection by French National Agency for Medicines and Health Products Safety (ANSM).- Manage the transfer of the documentation system from Sanofi to FAREVA (about 600 documents).- Plan and check the update of documentation (SOP, Manufacturing Batch Record, Forms...).- Create procedures to organise the activity in compliance with the cGMP.- Set up an EDMS in order to have a better use of operational documentation (establishment of software requirements specification). Show less

Lecturer in Quality Assurance at the Paris Diderot University Master's degree of Biology Engineering - Quality basic training module.

As a Quality Coordinator my mission were to ensure:- Daily management of the documentary system (about 600 documents) for the integrated quality management system - quality, environment, security and occupational safety.- Monitoring of the learning solution on Standard Operatind Procedures and Work Instructions.- Management of general document review.- Monitoring of KPI.

- Realisation of a report on the existing documentary system (based on the ISO 9001:2008 requirements).- Simplification and reorganisation of the documentary system so as to extend the scope of the approach (reducing by half of the overall documentary system).- Follow up of the quality improvement action plan set up in expectation of the certification renewal audit (certification renewed in December 2011).

Conduct of a self-assessment of the performance of the existing process implemented in the medical laboratory.Follow-up of the improvement action plan with the objective to fulfill the requirement of the standard within the limits fixed by the top management (certification expected in 2015 without any regulatory obligation in Cameroon).Construction of a documentary system to ensure effective planning, operation and control of the processes and comply with the ISO 15189… Show more Conduct of a self-assessment of the performance of the existing process implemented in the medical laboratory.Follow-up of the improvement action plan with the objective to fulfill the requirement of the standard within the limits fixed by the top management (certification expected in 2015 without any regulatory obligation in Cameroon).Construction of a documentary system to ensure effective planning, operation and control of the processes and comply with the ISO 15189 requirements.Training to make personnel sensitive to quality and its significance. Show less

Creation of protocols for cleaning validations.Monitoring of the samplings and its analysis in the laboratory.Preparation of the validation file. Follow-up of cGMP, EFfCI, ISO 9001 audits and audits client.