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Aurore MercierAM

Aurore Mercier

Quality Coordinator

€700/day
Rouen, FR
8-15 years
User Training
IT System Validation
Equipment Qualification
Data Integrity
Project Management

Average response time: 1 hour

Freelancer profile translated to English.
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About Aurore

With 14 years of experience in pharmaceutical quality, I bring structured, solution-oriented expertise. Passionate about people, skills development, and process improvement, I want to use my analytical and cross-functional abilities to contribute to positive impact projects within or outside the pharmaceutical sector.

  • French

    Native or bilingual

  • English

    Conversational

Can work on-site
Rouen (up to 50km)

Experience

  • CONSULTANTE INDEPENDANTE POUR SANOFI AVENTIS (LE TRAIT)
    COORDINATOR
    PHARMACEUTICALS INDUSTRY
    January 2022 - January 2026 (4 years)
    Implementation of the validation strategy for electronic batch records under MES (Werum) in project and routine mode.

    Validation of electronic batch records for packaging/solution preparation/material preparation/filling/visual inspection.

    Training of consultants on the implemented strategy.

    Planning and coordination of validation resources between different departments.

    Implementation of the VSI (Validation System Integration) training within the validation department.

    Facilitation of training sessions.
  • CONSULTYS POUR SANOFI PASTEUR (VAL DE REUIL)
    COORDINATOR
    PHARMACEUTICALS INDUSTRY
    January 2019 - January 2021 (2 years)
    Definition and deployment of the Data Integrity approach on site (audit of all site IT systems).

    Supervision of the team responsible for carrying out DI evaluations.

    Implementation of monitoring indicators, KPI tracking & reporting to management.

    Support for audit preparation.

    Monitoring of the site's 2020 quality plan.
  • CONSULTYS POUR SANOFI AVENTIS (LE TRAIT)
    IT SYSTEM VALIDATION CONSULTANT
    PHARMACEUTICALS INDUSTRY
    January 2017 - January 2019 (2 years)
    IT and process validation representative on the serialization/aggregation implementation project (qualification of the solution + equipment).

    IT validation representative on the CMMS implementation project.
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Education

  • MASTER IN PHYSIOLOGICAL ENGINEERING
    2012
    MASTER PROFESSIONNEL GENIE PHYSIOLOGIQUE
  • MASTER OF APPLIED SCIENCES IN BIOLOGY
    RENNES
    2010
    MASTER STS MENTION BIOLOGIE
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