Solène RICHARD

Lead design of the sealing process for the commercial machine for the production of inhaled products using a new medical device, lead filling process improvement and roll out to development machine Continuous improvement / further industrialisation of existing In Process Control equipments 6 Sigma project: improvement of the quality of the medical device components (plastic moulding process) Key facilitator for technical discussions between Amboise Manufacturing Site and Research and Development teams in UK

Implementation of the Global LIMS PFIZER Core Application (SQL*LIMS – LabVantage Solutions) and adaptation of core laboratory business processes at the Amboise site. Team Management (6 laboratory technicians and 11 contractors) Maintain adequate cost and schedule control according to the budget (1M€) Close teamwork and communication (Steering Committee, US Technical Teams, Suppliers)

Define and ensure the commissioning and qualification strategy described in the Master Plan document for the facilities and equipment required for the production of Ph III and ICH lots of inhaled products using a new medical device Responsible for the timely delivery of commissioning and qualification steps in accordance with the project plan - Maintain adequate cost and schedule control according to the budget (3M€) Close teamwork with Sandwich and Cambridge Research and Development teams (mutual support, understanding, trust) and European equipments suppliers. Improvement of site quality systems in accordance to ISO13485 standard Supervision of OEB4 tests on manufacturing equipments with EHS department

Qualification of Dry Forms Equipments and Validation of computerized systems Qualification of HVAC systems, clean rooms and systems for production and distribution of process fluids 6 Sigma project leader certified (improve SOP’s lead time approval, reduce leadtime of Viagra manufacturing) Quality documentation management (SOP’s, change control, validation master plan) Quality follow-up of calibration activities Participation in corporate audits and inspections (French agency, FDA…) - Internal auditor GMP trainer Member of international groups for process continuous improvement (commissioning and qualification European user group, computer validation network)