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Chiheb A.CA

Chiheb A.

Supermalter

Medical Device Projects Quality Engineer

€550/day
Lyon, FR
8-15 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Chiheb

Quality and Project Engineer in the medical device and pharmaceutical sectors. My experience focuses on the implementation of quality systems (ISO9001, ISO13485, GMP, GDP..) and quality projects. My pragmatic approach allows me to provide effective solutions while ensuring compliance and continuous process improvement. My experiences in multinational companies, which sparked in me a desire to master foreign languages and understand cultures, have led me to develop open-mindedness and a taste for challenges.
  • English

    Native or bilingual

  • French

    Fluent

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

Experience

  • Becton Dickinson
    Project Quality Leader - Life Sciences consultant
    PHARMACEUTICALS INDUSTRY
    March 2026 - Today (3 months)
    Grenoble, France
    Industrial transfer and production capacity extension projects for the account of Becton Dickinson.
  • PharmaGenius Distribution & Representations
    Project Manager
    PHARMACEUTICALS INDUSTRY
    February 2024 - Today (2 years and 4 months)
    Lyon, France
    • Manage the launch project of PharmaGenius (Organization, planning, resource management)
    • Implement a quality and compliance management system.
    • Train the team on ISO 13485
    • Implementation of an ERP Odoo software (Sample management, invoicing, supplier list...)
    • Negotiation of partnership projects with companies in the pharmaceutical and medical device fields. (Tunisia, Turkey, Jordan)
    ISO 13485 QMS Medical Devices Project Management KPI
  • Medtronic
    Quality Consultant
    CONSULTING AND AUDITS
    October 2022 - December 2023 (1 year and 2 months)
    Lyon, France
    Objectives
    • Implementation of a batch release process and compliance of batch records according to ISO 13485 and GMP.
    • Improve the collection and recording of quality data.
    • Contribute to the site's ISO 13485 certification. Missions
    • Conduct a situational analysis and a gap analysis between standard requirements and current practices.
    • Propose a roadmap for bringing practices related to batch release into compliance.
    • Improve the system for collecting and recording quality-related data.
    • Compliance of batch records according to GMP.
    • Implementation of a batch release process.
    • Promotion of a quality mindset.
    • Train production staff on good documentation practices.
    • Train batch release technicians on the new release process.
    ISO 13485 MDR 2017/745 GDP Documentation Audit

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Education

  • National Diploma in Chemical Engineering,
    Université Libre de Tunis (ULT)
    2016
    Diplôme national d'ingénieur en génie chimique,
  • Bachelor's degree in Chemical Process Engineering,
    Institut Supérieur des Études Technologiques
    2012
    Licence en génie des procédés chimiques,

Skill set

Categories

  • Other