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Carolina BASTIDAS

MULHOUSE

En résumé

I have a strong interest and real skills for medical and pharmaceutical technologies.

The idea to accomplish my career goals bring me to France to study and work in an international environment and high technology.



Mes compétences :
ISO 13485
ISO 17025
Internal Audit
Quality
OHSAS 18001
NF S 96-900
Métrology
CE-Marking
GCLP
Norme ISO 9001
Risk Assessment

Entreprises

  • Firalis - Quality assurance Manager

    2012 - maintenant Company’s quality assurance system management
    Quality representative in the CE-marking project for IVD products (European Directive 98/79 CE)
    Project manager in the ISO 13485 and ISO 9001 certification of the ELISA kits (IVD medical devices), antibodies and proteins production unit
    Project manager in the ISO 17025 accreditation of clinical/preclinical samples testing department;
    Project manager NF 96-900 certification for the biobanking activities (on going)

    Key Tasks and achievements:

    General quality management
    Risk management and change control management
    Internal audits management and realization
    Training of new internal auditors
    Supplier’s evaluation and qualification
    Supplier and client audits management and realization
    Non-conformities management and CAPA execution
    Documental system management
    SOP creation, review and approval
    Management review organization and animation
    Reporting to the company direction and CEO

  • Altran - Internship in the research and development unit « Medic@»

    Vélizy-Villacoublay 2011 - 2012 R&D of software for manipulates 3 dimensional medical images with the Kinect.

  • Gestion Biomédica S.A.S - Cofounder and Consultant

    2010 - 2010 Co-founder and Counselor in health and quality normativity.

Formations

Réseau

Annuaire des membres :