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Olivier LELOUP

Le Pont de Claix

En résumé

Fev 2018 - Jan 2019 - Product Safety Leader - Becton Dickinson

Safety assessments
- Evaluations related to toxicology, materials of concerns (REACH, heavy metals, phthalates, PVC, latex), worldwide regulatory requirements, Extractables and Leachables
- Living Risk Management of products and manufacturing processes
- Strong interactions with clinical trials, market complaints related to syringes and their components (glass, elastomers, plastic safety or autoinjection add-ons)

Biocompatibility product evaluation
- Biological Evaluation Reports (prefilled glass syringes)
- Materials, suppliers, additives impact management
- Manufacturing processes impact management (4 worldwide plants, billions of products annually)
- Change control impact management
- ISO10993-1, FDA, ICH, USP/EP, PDA, EMEA, CFDA regulatory landscape

Product development team member
- User risk analysis owner and global risk management per ISO14971 requirements
- Product development and life cycle management
- Handling of all safety-related tasks



2006 - Jan 2018 : Tornier - Grenoble - Responsable Qualité Validation
CA : 100 Millions d’euros, 400 personnes

• Mise en place d'un VMP global (Validation Master Plan) et des Plans de Validation procédés (ISO13485:2003, 21CFR820) : France, Irlande, US.
• Validation des procédés spéciaux pour des implants orthopédiques et ancillaires (passivation, nettoyage, conditionnement, stérilisation, revêtements, biocompatibilité).
• Validation de salle blanche et d'équipement de production (système d'eau purifiée, production d'air comprimé et de gaz inertes purs, bancs de test de scellage, etc.)
• au sein du service Qualité, participation à la gestion de CAPA, NC, amélioration continue.

2005-2006 : Swiss Medical Care SA - Lausanne, Suisse - Ingénieur Qualité
• Responsable qualité pour le développement, le transfert production et la validation de procédés.
• Soutenir le développement d’un injecteur pour la radiologie.

2005 (CDD 6 mois) : Medtronic France, Inc - Boulogne Billancourt - Responsable affaires réglementaires et matériovigilance
CA : 224 millions d’euros, 500 personnes.

• Gérer la matériovigilance de l’ensemble des produits Medtronic.
• Interagir avec les autorités compétentes françaises.

2004 (CDD 8mois) : Institut Pasteur de Dakar - Dakar (Sénégal) - Ingénieur R&D contrôle qualité
150 personnes, Laboratoire de production du vaccin de la fièvre jaune.

• Développer et mettre en place un nouveau test qualité de stérilité du vaccin par cytométrie de flux (FACScalibur).
• Mettre à jour le système qualité ISO 9001 de tout l’institut. Audit OMS réussi en 2004 après mise aux normes européennes

2001-2003 : Hôpital pour enfants de Montréal, Montréal (Canada) - Ingénieur R&D

• Développer une sonde de glycémie implantable, utilisant des techniques de génie moléculaire et de chromatographie.

Acquis :
• Aisance avec PCR temps réel, microscopie fluorescence, radioactivité.
• Dépôt d’un brevet canadien.
• Subvention américaine de 100,000USD.


1999-2001: Biosyntech, Inc, Montréal (Canada) - Stage + CDD 1 an - Ingénieur R&D
23 personnes

• Développer un biogel implantable résorbable (libération de médicaments, etc.)
• Mettre en place les BPL/BPF/ISO 9001.

Acquis :
• Tests de biocompatibilité in vivo/in vitro.
• Accréditation ISO 9001 obtenue en 2001.

Formation :
Ingénieur UTC (Biomatériaux Biocomopatibilité) – 1999
Master MscA Génie Biomédical – Ecole Polytechnique de Montréal, Canada - 2001

Mes compétences :
Biomédical
Biotechnologies
Développement de produits
Qualité
Validation
Toxicologie
toxicology
Living Risk Management of products and manufacturi
Clinical Trials
impact management
Product Development
Risk Analysis
Orthopedics
functional support
Additive Manufacturing
Process Development
VMP management
IQ OQ PQ
Assembly Plants
Audit
GMP
ISO 13485
Medical Devices
Risk Management
Develop an implantable biodegradable gel
Diabetes
In Vitro Studies
Quantitative PCR
In Vivo Studies
Immunization
Radiology
Flow Cytometry
Quality Management
ISO 900X Standard
Adobe Photoshop
Data Processing
Microsoft Excel
Microsoft Office
Microsoft PowerPoint
Microsoft Word
SAP

Entreprises

  • Becton Dickinson - Product Safety Leader

    Le Pont de Claix 2018 - 2019 Becton Dickinson - Pont De Claix, France (1700 people on the site) - worldwide leader in Prefilled Glass Syringes
    * Safety assessments
    Evaluations related to toxicology, materials of concerns (REACH, heavy metals, phthalates, PVC, latex), worldwide regulatory requirements, Extractables and Leachables
    Living Risk Management of products and manufacturing processes
    Strong interactions with clinical trials, market complaints related to syringes and their components (glass, elastomers, plastic safety or autoinjection add-ons)
    * Biocompatibility product evaluation
    Biological Evaluation Reports (prefilled glass syringes)
    Materials, suppliers, additives impact management
    Manufacturing processes impact management (4 worldwide plants, billions of products annually)
    Change control impact management
    ISO10993-1, FDA, ICH, USP/EP, PDA, EMEA, CFDA regulatory landscape
    * Product development team member
    User risk analysis owner and global risk management per ISO14971 requirements
    Product development and life cycle management
    Handling of all safety-related tasks

  • Wright Group - Process validation manager

    2006 - 2018 Validation / Process Industrialization / Biocompatibility expert
    (450 people in France, 2000 people worldwide) - Orthopedics implants
    * Process Validation / Industrialization
    Cross-functional support for product and process development teams in relation with special processes
    (Passivation, cleaning, packaging, heat-treatments, surface treatment, coatings, gamma and moist-heat sterilization, cleanroom, water/air production systems, metal additive manufacturing)
    Materials and process innovation and customization
    VMP management : FAT, SAT, IQ, OQ, PQ methodology.
    Definition of monitoring plans
    2 Manufacturing plants
    Supplier auditor
    GHTF, GMP, ISO13485, RIM references

    * Biocompatibility
    Biocompatibility assessment per NF EN ISO10993-1 and FDA guidance requirements (implants, instruments, packaging, stability).
    Member of TC194 standardization group (biocompatibility, ISO10993 serie)
    Member of S93P AFNOR group for Medical Devices standardization (materials, cleaning) and S95P group for sterilization and packaging of Medical Devices
    Reviewer for biological evaluation reports for medical devices : E&L methods, toxicological profiles evaluations, risk management, review of regulatory/standards updates (ICH, FDA, OECD, PDA, EMEA, USP...)
    * Multicultural demanding environment : international-based group with growing regulatory expectations with a double digit- growth to support
    * Strong interactions with other departments
    Quality : deviations, customer complaints, change control, harmonization between Tornier-Wright sites
    Purchasing : supplier specifications, controls, audits
    Regulatory : worldwide submissions for CE market, FDA, Japan, Brazil, China...
    Production : training...
    * 2 FDA inspections, 1 Brazil inspection, 1 Korea inspection, 2 ANSM inspections

  • TORNIER - Responsable validation procédés spéciaux

    Montbonnot Saint Martin 2006 - 2018

  • SwissMedicalCare - Quality Engineer

    2005 - 2006 * Development of a radiology injector
    Quality management (deviations, customer complaints, change control)
    Supplier process validations, audits
    CE market, FDA

  • Medtronic - Regulatory Affairs and Customer Complaints Manager

    Boulogne-Billancourt 2005 - 2005 * Customer Complaints and Non-conformance management
    Very wide range of medical devices
    Interactions with ANSM for recalls, field actions
    Customers-oriented Interactions

  • Pasteur Institute - Quality and R&D Engineer

    2004 - 2004 Develop and implement a sterility control test for routine vaccine production through Flow Cytometry
    Update the QMS to ISO9001 standard for the whole institute
    Users training
    Successful WHO audit after implementation

  • McGill University - Quality Engineer

    2001 - 2003 Develop an implantable sugar probe for diabetes treatment
    Molecular Biology tools (real-time PCR, fluorescence microscopy, radio-isotopes)
    International congress presentation (Atlanta, GA)
    United States Patent US 20040108226 A1

  • Biosyntech - Ecole Polytechnique de Montréal - R&D Engineer

    1999 - 2001 Biomedical Engineering MScA internship + 1-year contract
    Develop an implantable biodegradable gel for drug/cell release
    Biocompatibility evaluation in vitro/in vivo
    Implement ISO9001, GLP, GMP practices

Formations

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