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Antoine BOULIER

Courbevoie

En résumé

Chemical Engineer and Doctorate in Pharmacy
Currently Corporate Operational QA Manager
Specialized in Quality & Technical Regulatory Affairs
Has been Deputy Responsible Pharmacist (Qualified Person)

Mes compétences :
Analyse de risques
Management
Qualité

Entreprises

  • Galderma - Corporate Operational QA Manager

    Courbevoie 2016 - maintenant - Member of the global QA organization
    - Responsible to monitor and promote Operational Quality (release, QC, deviations, CAPA…) within the Galderma production sites
    - Supervise & coordinate the sites CMO Quality Teams in the scope of Cosmetics, Drugs, Food Supplements and Medical Devices.
    - Enhance quality continuous improvements actions
    - Develop quality business excellence approach across sites & CMOs.

  • Abbott Laboratories - Product Support & Compliance QA Manager

    Rungis 2013 - 2016 - Member of the global QA organization
    - Management of the Change Request Process
    - Write / Review and Approve CMC documents for consistency with Abbott policies and guidelines
    - Participate in the regulatory strategy (Variation / Deficiency letters)
    - Management of the Technical Transfers – Quality Part (from Abbott Plants to TPM or from TPM to another TPM)
    - Support resolution of (critical) issues according to internal rules
    - Team Member for global production transfer between plants of the company
    - Team Member in the Product Work stream and participation of strategic decisions

  • Abbott Healthcare SAS - Regulatory Compliance & Quality System, Deputy Responsible Pharmacist (QP)

    2008 - 2013 - Deputy Responsible Pharmacist – Qualified Person
    - Management of Global Quality Systems used by the plant
    - Insure the regulatory and GMP compliance for the plant
    - Management of the Change Request Process
    - Management of the Quality Risk Management
    - Relationship with French Health authorities for all regulatory data of the plant (Site Master File, Annual Narcotic submission, Pharmacist inscriptions, GMP Certificate, …)
    - Team Member for global production transfer between plants of the company
    - Team Member as Global Operational Quality Assurance during global meeting
    - Write / Review and Approve CMC documents impacting the Abbott Chatillon plant
    - Management of the Local IT validation
    - Maintain regulatory agreement (AFSSAPS, FDA, …) and external customer
    - Participation to regulatory inspections:
    - Presentation of Quality systems and process,
    - Management of the Back-room during inspections/audits and in particular during FDA inspection

  • Pierre Fabre - QA CMO Manager & QA Project Manager

    Castres 2005 - 2008 - Management of the product switch :
    o Contribution to the definition of the product status (Medicinal Product, Medical Device, Cosmetic product, …),
    o Coordination of all stakeholder for the development of a new project :
    - Marketing Department / Research Department/ Sale and Logistic Department / QA Department
    - Corporate Quality Assurance System
    - Creation of all the QMS documentation for a new entity (specialized in Medicinal Product) in conformity with ISO 13485:2004
    - Participation in the elaboration of Product Development Generic Process.
    - Certification of Third Party Manufacturers (Pharmaceutical / Cosmetic / Medical Device) for PFM (30/35 TPM worldwide)
    - Management of external audits (10-20 audits)
    - Management and Writing of Quality Agreements with TPMs
    - Management of complaints (internal and external)
    - Participation in regulatory monitoring and updating of the quality policy
    - Management of industrial transfers (production and analytical)

  • Laboratoires Macors - Head of QC

    2003 - 2005 - Management of a group of 20
    - To ensure the optimization of management of staff, of the organization of the department (Data processing, automatization, security…) and of personal development.
    - Relations with scientific department and/or customers, to ensure the scientific support for all the analytic aspects (security, adjustment of method, support of production, validation …).

Formations

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