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Malt Strategy
Jean Marc Nitcheu TepouJM

Jean Marc Nitcheu Tepou

Supermalter

Consultant VSI - CSV

€750/day
1 project
Paris, FR
8-15 years
Anglais
Microsoft Office
Validation CSV
ISO 13585
Redaction de protocoles IQ OQ PQ

Average response time: 1 hour

About Jean Marc

Computerized Systems Validation Specialist and Lean Project Manager with solid experience in leading cross-functional operational excellence initiatives in the healthcare sector. I integrate frontline insights captured through training delivery, verification activities, and validation processes in collaboration with field engineers. Passionate about innovation, I am eager to leverage my technical expertise and personal strengths to create value. I have a strong interest in the medical device and pharmaceutical industries, particularly in conducting computerized systems validation (CSV) activities, as well as in the qualification and validation of medical devices.

  • Biomedical Engineer
  • Certified Agile Software Product Owner
  • Lean Six Sigma Green Belt
  • Professional Scrum Product Owner (PSPO I)


Medical Devices
Pharmaceuticals
Biotechnologies
Consulting and Audits
Software Publishing

  • English

    Fluent

  • French

    Native or bilingual

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

Experience

  • Ipsen Pharma
    Consultant Qualité IT - VSI
    PHARMACEUTICALS INDUSTRY
    November 2024 - June 2025 (7 months)
    Boulogne-Billancourt, France
    Project Title:
    IT Quality Assurance and Data Integrity

    Objectives:

    • Ensure compliance of the validation documentation for the systems: ATOLS, COMANDO, GAMS, DATAVISION, and VISION TRACKER
    • Conduct periodic reviews
    • Validate tools in accordance with GAMP 5 guidelines

    Achievements:

    Review and Approval of All Project Deliverables

    Review and approval of system impact assessments, functional risk analyses, validation plans, qualification protocols, test scripts, reports, Go-Live authorizations, qualification and validation in compliance with ISO 13485:2016 and FDA 21 CFR Part 11

    Review and Approval of Work Instructions

    Review and approval of Change Control requests and CAPA management procedures related to changes implemented directly in production

    CFR 21 Part 11 Validation CSV Système qualité ISO 13585 Microsoft Office
  • Sanofi
    Consultant Qualité IT - VSI
    PHARMACEUTICALS INDUSTRY
    June 2023 - September 2024 (1 year and 3 months)
    Neuilly-sur-Seine, France
    Project Title:

    Validation of the TraceLink Serialization System and Implementation of a QMS for Serialization Activities

    Objectives:

    • Implementation of a Quality Management System (QMS)
    • Drafting and updating of validation deliverables for the TraceLink system
    • Validation in accordance with GAMP 5 guidelines

    Achievements:

    Drafting of Validation Deliverables for the TraceLink Serialization System

    Drafting of the validation plan, qualification protocols, test scripts, release plans and reports, qualification and validation in compliance with ISO 13485:2016 and FDA 21 CFR Part 11

    Drafting and Updating of SOPs for Serialization Activities

    Drafting of procedures for Business Continuity Planning (BCP), Change Control, CAPA Management, Incident Management, Monitoring, Audit Trail, User Management, etc.

    Creation of Work Instructions for the TraceLink System

    Development of detailed work instructions to support system use and compliance

    Onboarding of CMOs on the TraceLink Platform

    Coordination and validation of the onboarding process for 17 Contract Manufacturing Organizations (CMOs) on the TraceLink platform
    CFR 21 Part 11 Validation CSV Système qualité ISO 13585 Transformation digitale
  • Sanofi
    Consultant VSI
    PHARMACEUTICALS INDUSTRY
    June 2022 - December 2022 (6 months)
    Lyon, France
    Project Title:

    Development of a Website for the Dematerialization of Vaccine Leaflets in a GxP Environment

    Objectives:

    • Ensure compliance of the validation documentation for the ePI (eProduct Information) system
    • Drafting and updating of validation deliverables
    • Validation in accordance with GAMP 5 guidelines

    Achievements:

     Drafting of All Project Deliverables

    Drafting of the validation plan, qualification protocols, test scripts, release plans and reports, qualification and validation in compliance with ISO 13485:2016 and FDA 21 CFR Part 11

     Drafting and Updating of Change Management Instructions

    Drafting of the Change Control procedure for each type of change (structural/code changes, site initialization, version upgrades, site decommissioning)
    Creation of a simplified content management procedure via service requests on ServiceNow
     IT Tool Validation

    Drafting of validation deliverables for each release (Agile Scrum methodology with bi-weekly sprints/releases)
    Drafting and execution tracking of test cases
    Validation CSV ISO 13585 Méthode agile Microsoft Office Agile Scrum
Check out Jean Marc's experience

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Education

  • Ingenieur Biomedical
    Polytech Marseille
    2015
  • Sofware Product Management Specialization
    University of Alberta
    2019
    Introduction to Software Product Management Software Processes and Agile Practices Client Needs and Software Requirements Agile Planning for Software Products Reviews & Metrics for Software Improvements Software Product Management Capstone
Check out Jean Marc's education

Certifications

Skill set

Spécifications fonctionnelles
Méthode agile
Transformation digitale
C, PHP
Amélioration des processus Lean
C (langage de programmation)
CFR 21 Part 11
Agile Scrum
Système qualité

Categories