Mes compétences :
Gestion de projet
Industrie pharmaceutique
Lean Six Sigma
Management
Gestion de projets internationaux
Conduite de changement
Transaction Processing Monitor
Entreprises
Avertim
- Consultant PMO
PARIS 82014 - 2015Project: Mission GSK on both sites Wavre and Rixensart of NPI unit: Coordination of a new candidate vaccine for Japan (preclinical and clinical phase I-III) as part of a transfer of technology and supervision the quality system to reduce the backlog.
Project manager (change the line / Production viral vaccine/ technology transfer)
o Coordinate interactions Formulation / filling / Packaging / Validation / raw mat creation / Master Data / QA / Logistics via the imperatives of customer
o Plan schedule and monitoring of projects, technology transfer, modification of a line of filling and Production (Validation / process / QA)
o Escalation of problems and propose solutions
o Support to the drafting of transfer documents (transfer level, transfer endorsement, transfer risk assessment, transfer close out)
o Supports Transfer Plan
o Oversee the qualification of raw mat for lots of transfers, IQ / OQ / PQ, machinery as well as preclinical and clinical trials batches
o Oversee the equipment validation, cleaning
o Management of operator training related to the project
Quality system supervisor
o Supervise the compliance of GMP
o Management of problematic quality NPI unit
o Implementation of resolution methods
o Deviation, CAPA, Change Control, Batch record
Indicators:
o Implementation Project and indicators of the quality system
Results:
o Preclinical Phase completed on time / cost / quality
o Clinical Phase I and II completed on time / cost / quality
o Reduction in the backlog of quality system (average -70%):
-100% Deviation, -80% CAPA, -65% Change Control, -35% Batch record
Paris2013 - 2013Project: Implement a level of Quality Assurance on the clinical trial phase I/II for a vaccine candidate AIDS equivalent to that required by the ANSM (agence national de sécurité du médicament).
Project Manager
o Supervise the compliance of GCP
o Write a “fresh eyes” report
o Design the Action Plan (CAPA)
o Update procedures and documents Quality Management (BPC, ISO 17025, ISO 1548 and ICHQ2)
o Write Quality documents
o Create an EDM, an intranet page
o Manage metrological checks and maintenance on equipment
o Develop management tools differences (deviations)
o Develop a plan for validation of analytical methods specific to the project sponsor
o Establish standardized raw journals tools and treatment results
o Implement regulatory surveillance
o Draw up the quality budget
o Educate and train staff Unit in Quality and a Quality Coordinator
o Create an induction, training and skills booklet
o Change management
Indicators:
o Creation of multiple management tools: Deviation, Reagent, Equipment
Results:
o Quality management system answering to requirement of the ANSM (agence nationale de sécurité)
o Implement Quality Mindset in team
FAREVA
- Supply Chain Project Manager
Romainville 2012 - 2012Project: Management and optimisation inventory control on the Valdepharm site.
Project Manager:
o Write a “fresh eyes” report
o Design the Action Plan
o Map storage areas
o Analyse stocks in value and volume
o Increase the chemical productive capacity
o Improve the chemical reactors capability (Statistical Process Control)
o Decrease the time of the manufacturing process: On one product (gain: 5 days on a lead time of 45 days)
o Deviations management (follow up and resolution issues)
o Establishment an analyse approach on others products
o Supervise the compliance of GMP
o Provide the Production Plan
o Follow feasibility studies (technology transfer)
o Change management
Indicators:
o Create a fill rate of warehouses
o Create a provisional and real filling products
Results:
o Freed up storage space (about 1500 m2)
o 3 products analysed
Volume gain: 201 emplacements (about 300 m2)
Value gain: 480 000€
CiToxLAB
- Preclinical Studies Coordinator
Évreux2005 - 2011Mission: Ensure the achievement of the preclinical studies (rodent, rabbit, pig, dog, and monkey) in terms of Quality and on time delivery.
o Project management
o Risks management
Project Manager
o Transversal management
o Follow preclinical studies
o Validate administration methods
o Integrate the quality, safety, technical and regulation aspects
o Supervise the compliance of GLP
o Deviations management (follow up and resolution issues)
o Realize internal audits
o Write specifications, SOPs, operating procedures and forms
o Participate to draft experimental protocols
o Realize feasibility studies (technology transfer)
o Train the new entrants the regulatory requirements
o Follow skills and accreditations of new entrants
Blagden Packaging
- Supply Chain Team Manager
2001 - 2003 Mission: Ensure the achievement of the planned production.
• Actions accomplished:
o Lead a team (5 to 6 people)
o Follow product plan
o Monitor product Quality
o Manage stock control
o Order planning
o Increase the productivity (+3%)
o Contribute to the continuous improvement
o Manage the quality compliance
Formations
British Study Centres School Of English. (Londres)
Londres2015 - 2016cambridge 1-2; niveau C1-C2; Toiec 875-950 points
