Menu

Arnaud RANDRIANA

Maurepas

En résumé

Double skilled, pharmacist I performed a master in regulatory affairs with a specialization on medical devices and associated drugs (ie. Master).

From 2006 to 2009, I have been working as Head pharmacist, leading regulatory affairs activities and managing its quality system. Main achievements are from new product registrations to batches delivery, contract notices, ISO certifications, as well as adaptation and optimization of internal processes to the evolving quality environment.
Cross functional teamwork and development of partnerships increased my interest and abilities for project management. This position in a high growth rate company also gave me the opportunity to improve my understanding of local business requirements, knowledge of international standards and regulations related to global marketing of medical devices and associated drugs.

At this stage after having structured the quality and regulatory affairs department, I was eager to working in an multicultural environment.

Looking for this new business environment, scopes and with the willing to implement R&D activities in an international context, since January 2009, I am Project Manager taking part of R&D activities of innovating therapies. Coordinating activities in premarket phases for a global dialysis technologies manufacturer, setting-up and implementing QA & RA frame of project, aiming to optimizing time and investments, my focus is especially to reaching user needs while respecting applicable standards and requirements.

Mes compétences :
Développement
Pharmacien
Management

Entreprises

  • Baxter International - Site QA R&D manager

    Maurepas 2013 - maintenant
  • GAMBRO - QA/RA R&D Project Manager

    Meyzieu 2009 - 2013 Leading QA/RA questions related to a therapeutical active MD development process
  • Tekka - Head Pharmacist

    2006 - 2008 SKILLS:
    - Implementation and follow up of product registration and company’s certificates for France and abroad
    - Definition of regulatory and normative requirements
    - Adaptation of the quality management system
    - Operational unit management

    JOB:
    Regulatory affairs:
    - accountable for CE marking, registration in Brazil and US accreditations
    - regulation and standards surveillance
    - in charge of review, approval and transmission to internal and external partners
    - official correspondant of authorities
    Quality assurance:
    - audit and quality system management adaptation and optimization
    - internal training for environmental requirements
    - management of corrective quality actions and customers complaints
    - in charge of traceability and reliability of batches
    Definition of regulatory scope and project management
    design and implementation of:
    - a clean-room equipped to wash and package implants
    - a surgical area
    Request for quotation manager: research, internal coordination and proposal

Formations

Réseau

Annuaire des membres :