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Juan Guillermo BERNAL BONFANTE

Marly-le-Roi

En résumé

Juan Guillermo BERNAL is an operational consultant, with specific skills in Bio production and Quality Assurance for the biopharmaceutical industry under cGMP & EuGMP requirements.

Juan is graduated from Institut National des Sciences Appliquées (INSA) de Toulouse as a biochemical engineering and has a double training in High Tech Environment Management.

During his first project, Juan worked for Pierre Fabre Médicament Production. All through his assignment, he acquires strong skills in process validation and manufacturing equipment. In few months, he showed great capabilities to work in changing environment
Juan has strong interpersonal skills and shows great capabilities to work in multicultural teams, acting as a positive change driver.

Juan also worked for GlaxoSmithKline Vaccines, as deviation management team coordinator. Through this experience, Juan developped management skills in a complex context.

Juan Bernal can bring his knowledge in the following areas:
- Technical & risk analysis of industrial production plants
- Qualification & validation (documentation review, execution , coordination IQ/OQ/PQ)
- Project management and coordination of multidisciplinary cross departmental teams
- Operational QA support (under cGMP regulations)
- Client relationship
- Originally from Colombia, he is proficient in Spanish, French and English. He is able to manage international projects, particularly between Europe and the Americas.

Mes compétences :
Biochimie
Biotechnologies
Innovation
Innovation management
International
Management
Recherche
Veille

Entreprises

  • GlaxoSmithKline - Team Coordinator

    Marly-le-Roi 2014 - maintenant Coordination of a team of six consultants (production and QA) in the management of process deviations of the manufacturing unit.

    - Definition and monitoring of the team’s activities
    - Implementation of visual management tools
    - Implementation of project KPIs
    - Definition of weekly deviation closure objectives
    - Weekly reporting to the business unit and the client sponsor
    - Challenging of blocking points in order to stick to the clousre objectives
    - Benchmarking between manufacturing units in order to prupose continuous improvement actions

  • Pierre Fabre - Project Leader Deputy

    Castres 2013 - maintenant Steering of the integration of a new product for a new client in an existing workshop

    - Elaboration and coordination of the project planning with the whole project team (Production, Engineering, Maintenance, QA, Validation, QC, EHS, Logistics, from both companies)

    o Process Transfer (compounding, filling/lyophilization/capping, visual inspection)
    o New equipments integration
    o Analytical Transfer
    o Equipments Qualification
    o Process Validation
    o Creation of product related documentation (Validation Master Plan, MBR, SOPs, Methods, Protocols,...)

    - Monitoring and reporting to the project sponsors

    - Elaboration of project Change Control
    - Elaboration of process GAP analysis
    - Definiton of new equipments URS
    - Integration of raw material and packaging suppliers
    - Establishment of product Quality Agreement according to the client requirements

  • Pierre Fabre - Window Person

    Castres 2012 - 2013 Window Person for international clients
    - Coordination of communication between Pierre Fabre and two international clients.
    - Transversal management and operational support of Pierre Fabre commercial relationship.
    - Investigation in the different services in order to answer the clients’ requests.

    Support in:
    • Batch releasing
    • Logistics
    • Technical projects (process validation, risk assessment, GAP analysis)
    • QA : deviation follow-up, CAPA, change controls steering,...

  • Laboratoires Pierre Fabre - Stagiaire - Chef de Projet Junior - Développement pharmaceutique

    Castres 2012 - 2012 Je participe à la gestion de projets de développement pharmaceutique de plusieurs médicaments ciblant diverses pathologies:
    - Oncologie
    - Cardiovasculaire
    - Anti-inflammatoire
    - autres

    Mes missions:

    - Coordonner les échanges entre les différents métiers intervenant dans le développement pharmaceutique afin d'assurer le bon avancement des projets
    - Gérer la sous-traitance d'études pharmacologiques
    - Gérer le planning et le budget des projets
    - Participer à la réalisation des plans de développement cliniques
    - Développement d'une étude d'hématotoxicité inter-espèce afin d'optimiser une étude phase I en oncologie

  • Sanofi Pasteur - Stagiaire

    Lyon 2011 - 2011 Évaluation et analyse de faisabilité pour un projet de remplacement de colonnes de chromatographie industrielles, faisant partie d'un procédé de production de sérums.
    - Réalisation de bilans de matière, schémas bloc, et schémas procédé.
    - Etude technique des équipements industriels disponibles sur le marché et leur adaptabilité par rapport à l'existant.
    - Estimation coût/délai et préconisation d'une solution technique adaptée au besoin, au budget et au plannning.

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