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Kamel EL HARKANI

ANNEMASSE

En résumé

- Over 12 years of experience as Pharmaceutical Engineer within big pharma and industries.

- I have a developed knowledge of Quality Management and Quality Assurance activities such as Qualification & Validation of manufacturing Equipments, Medical Devices, lab instruments and utilities (CSV, 21CFR. 11, URS, IQ-OQ-PQ, FAT-SAT protocols writing and review), SOPs, Change Control and CAPA management within regulated environment (GLP, ISO 13485-9001-17025, cGMP, ICH-Q8, Q9, Q10).

- I have an excellent level of laboratory work (Quality control, Analytical Chemistry (HLPC-GC/MS), Formulation, Screening Science, Laboratory Automation, R&D projects).

- I managed and implemented several Technological Projects (design, suppliers selection, setup, scouting).

- I have a proven ability to adapt to new technologies, international environments and accustomed to using initiatives to meet tight deadlines.

Mes compétences :
GAMP 5
Risk Assessment
Equipement Qualification
Lean Six Sigma
Computerized System Validation
Process Validation
Quality Assurance
CGMP practices
Validation & Qualification
AMDEC/FMECA
ISO13485
Medical Device
Norme ISO 9001
ISO17025
SOPs writing and Review
Analytical Chemistry
Normes Qualité
High Throughput Screening
Quality Management System
Biotechnologies
R&D
Industrie pharmaceutique

Entreprises

  • Inventiva-Pharma - Lab Manager

    2014 - 2015 - Chemical Compounds Logistics and Workflows coordination (Storage, Weighing, Dissolution, Orders, Screening, plates production)
    - Team Management (3 Senior Technicians)
    - Data management on Mosaïc LIMS (Titian®)
    - Implementation of Quality Management System (SOPs, Internal Audits, CAPA, Staff training,
    presentations)
    - Robotic platforms (Liquid handlers, Automated Tubes Storage) and instrumentation management
    (Maintenance contracts review, Technologies Scooting, Staff training)

  • Merck Serono - Technological Project Coordinator - Validation Engineer

    Lyon 2009 - 2013 - Project Definition
    - Project Teams selection and coordination
    - Design creation and User requirement definition (URS)
    - Supplier Selection
    - Ordering Process & Negotiation
    - Equipment Validation & Qualification (Tests Protocols Writing and Review FAT, SAT, IQ/OQ/PQ)

  • Merck Serono - Quality Management System delegate

    Lyon 2008 - 2012 * Implementation of Quality Management System
    - Processes review
    - SOPs writing, review and management (DMS)
    - KQIs definition and setup
    - Internal Audits implementation and management
    - CAPA management
    - Scientific Staff training to QMS (presentations)

  • Merck Serono - Associate Scientist - Lab Automation specialist

    Lyon 2007 - 2013 - Responsible of a Global robotic platform : Liquid Handler/Multimod Reader/Arm (Design, Implementation, Programming, Troubleshooting, End-Users training)
    - High Throughput Screening and Biochemical Assay Plates creation
    - Biochemical assay Screener (FlashPlate, Radioactivity technologies)
    - Chemical compounds management (Storage, weighing, Solubilisation, Delivery)

  • Novartis Health Care - E-Compliance Officer

    2006 - 2006 - e-Validation of Gas Chromatography software (TotalChrom®) according to FDA-21CFR 11 regulation

    - Documentation compliance, Validation protocoles writing and reviewing (URS definition, IQ/OQ/PQ)

  • Merck Serono - Analytical Chemistry Technician

    Lyon 2005 - 2005 * Analytic control of chemistry compounds (HPLC, LC/MS)
    * Log D determination using robotic liquid handler RSP150 Genesis TECAN®
    * Thermodynamic solubility and Nephelometry determination

  • Royal Dutch Shell - QA/QC Chemist

    Paris 2003 - 2004 Quality Control Laboratory of lubricants production
    (ISO 9001 / 14001 / 17025) / Formulation, control and analysis of oils and greases lubricants produced in
    house
    - SOPs writing and review
    - Internal Audit
    - Reorganization of the laboratory focusing on safety and ergonomic layout (Processes review)
    - Management and training of foreigner students in placement
    - Waste cost’s management (reducing cost by 75% and increasing safety)
    - Quality Control & analysis of used water, chemical solvents and gas
    - Results recording, Analytical instruments maintenance

Formations

  • IASSC (Distance Learning) (Na)

    Na 2016 - maintenant LEAN -6-Sigma Green Belt Certification

    Certification to get well versed in the Lean Six Sigma Methodology who both leads or supports improvement projects.

    Provide a thorough understanding of all aspects within the phases of D-M-A-I-C. Allow to understand how to perform and interpret Six Sigma tools and how to use standard principles of Lean.

  • CEFIRA

    Boulogne Billancourt 2013 - 2013 Validations et qualifications dans les industries pharmaceutiques et apparentées

    Certification de formation

  • Conservatoire National Des Arts Et Métiers (Distance Learning)

    Paris 2009 - maintenant Ingénieur CNAM Chimie - Option Techniques Pharmaceutiques

    Drugs manufacturing, Galenic & formulation (Sirup / Pellets / Nanoparticles), Pharmacotechnics, Pharmacochemistry, Pharmacology, Analytical control,
    Management, Communication

  • Université Strasbourg 1 Louis Pasteur (Distance Learning)

    Strasbourg 2009 - 2012 Master R&D Pharmaceutique

    Pharmacology, Biology, PK/PD, Formulation, Galenic, Screening technologies, Pharmacochemistry, Project Management, Communication

  • Université Bordeaux 1 Sciences Et Technologies

    Talence 2000 - 2001 Licence Professionelle de Chimie Industrielle

    Formulation des Millieux Dispersés

Réseau

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