Some services offered around the management of a quality system:- setting up a quality management system or diagnostic approach of the existing,- equipment qualification, process validation- continuous improvement, process optimization- quality training- support on certification projects, preparation for an audit

Management of the quality system and continuous improvement: quality policy, quality documentation system, qualification and validation dossiers, internal audit program, follow-up of incidents, deviations, OOS, CAPA and change controls, quality metrics, annual quality review, quality risk management…Definition of the general compliance training plan and organization of the training sessions.Qualification of subcontractors and suppliersAcceptance of raw materialsReview of batch dossiers and clinical product releaseManagement of corporate inspections and ANSM inspectionsPreparation of year budget for QA group and follow budget executionTeam management (3 engineers and 1 technician)

Quality Management System definition of a new facility which is rapidly growing (first productions in 2010 and double digit growth rate until 2015): processes definition, quality documentation structure, management with quality metrics...Manufacturing records review and batch release according to customer specificationQuality documentation management (quality manual, SOP’s, raw material specifications, customer specifications...)Management of internal audits, customers audits, sub-contractors/suppliers auditsRe-certifications EN9100, OHSAS18001 – NADCAP certification in progressManagement of raw material non-conformities, internal non-conformities and customer claimsStandardization of european quality processes (France / Espagne / Allemagne)Training of new employees (25 in one year)Leading of continuous improvement projects and participation of new product industrializatio

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 machineContinuous improvement / further industrialisation of existing In Process Control equipments6 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 deviceResponsible 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 standardSupervision of OEB4 tests on manufacturing equipments with EHS department

Qualification of Dry Forms Equipments and Validation of computerized systemsQualification 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 activitiesParticipation in corporate audits and inspections (French agency, FDA…) - Internal auditorGMP trainerMember of international groups for process continuous improvement (commissioning and qualification European user group, computer validation network)

Etude de l'impact des propriétés d'une poudre pharmaceutique sur les réglages d'un compacteurRecherche bibliographiqueFormulation et plans d'expériences