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Florian SabrieFS

Florian Sabrie

Consultant - Health Sector Engineer VSI CSV

€780/day
Toulouse, FR
8-15 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Florian

As a qualification and validation engineer with 7 years of experience in the pharmaceutical industry, I specialize in Computerized System Validation (CSV) and master specific standards and regulations. I am committed to providing customized solutions to ensure the compliance and reliability of computerized systems. Working with clients in the pharmaceutical industry, my goal is to deliver high-quality results and maintain the highest standards of compliance. Together, we will ensure that your systems are rigorously validated and meet the strict requirements of the pharmaceutical industry.

  • French

    Native or bilingual

  • English

    Conversational

Can work on-site
Toulouse (up to 50km), Bordeaux (up to 100km), Bayonne (up to 100km), Montpellier (up to 100km)

Experience

  • Sabrié Conseil Industrie Santé
    Consultant - Qualification and Validation Engineer
    PHARMACEUTICALS INDUSTRY
    September 2021 - Today (4 years and 9 months)
    Toulouse, France
    Software Validation
    Pharmaceutical Industry (GMP)
    Support: 21 CFR Part 11 – FDA / Annex 11 (computerized systems) – GMP / GAMP5

    o GxP rating of ongoing change controls during committees
    o IT impact assessment of change controls requested during committees
    o Writing of IT IQOQ protocols
    >Writing risk analyses
    >Writing of TDFs (Test Description Forms)
    o Execution of tests
    o Writing of validation reports.

    o Writing of software validation and qualification:
    >IQOQ protocols and their test sheets
    >Risk analyses
    >IQOQ reports (Final reports)

    o Execution of different types of Qualifications:
    >Internal IQOQ execution
    >Supplier SAT supervision
    >Supplier IQOQ supervision

    Type of qualified software:
    o Validated production software:
    >KORSCH production software
    >SEAVISION production software
    >INEVER production software
    >FAUCHE production software
    >API TOUR 3
    >API TOUR 4
    >API TOUR 5
    >API TOUR 6
    >Tour 3 supervision
    >Tour 4 supervision
    >Tour 5 supervision
    >Tour 6 supervision

    Client:
    >UPSA



    Equipment Validation and Qualification
    Pharmaceutical Industry (GMP), Medical Devices (ISO 13485) and Primary Packaging Materials for Medicines (ISO 15378)
    Support: Annex 15 (qualification and validation) – GMP

    o Writing of an equipment validation procedure.
    o Implementation of a VMP (Validation Master Plan)
    o Update of the VMP and its planning
    o Support for equipment risk rating
    o Organization of different types of Qualifications:
    >Internal QI (Installation Qualification)
    >Internal OQ (Operational Qualification)
    >Internal PQ (Performance Qualification)
    >Supplier SAT (Site Acceptance Test)
    >Supplier IQOQ
    >Method Validation
    >Requalification

    o Writing of equipment validation and qualification:
    >Validation Plans
    >URS (User Requirement Specification) review
    >Risk Analyses
    >QI protocols and their test sheets
    >OQ protocols and their test sheets
    >PQ protocols and their test sheets
    >QI reports
    >OQ reports
    >PQ reports
    >Final validation reports

    o Execution of different types of Qualifications:
    >Internal IQOQ execution
    >Supplier SAT supervision
    >Supplier IQOQ supervision
    >Supervision of method validation execution

    Type of qualified equipment:
    o Laboratory equipment:
    >Autotitrator T9 METTLER TOLEDO
    >Halogen Dryer HX204 METTLER TOLEDO
    >Spectrum Two PerkinElmer
    >Melting Point MP80 METTLER TOLEDO
    >Vertex 311 HM-HC MICRO-VU
    >EXCEL 512 UM MICRO-VU
    >Water Production System HX 7040 SD MILLIQ and Distribution System IQ 7000 MILLIQ
    >Washer 1300LX Ultima
    >GC-MS-FID THERMO FISHER
    >Goniometer PGX+ LABOMAT
    >Dynamometer LS1 LLOYD INSTRUMENTS
    >Dynamometer LRX+ LLOYD INSTRUMENTS
    >Videomicroscope MICROVISION
    >Filtration System MILLIFLEX OASIS
    >Peristaltic Pump PUMP PMI BIOMERIEUX
    o Production equipment:
    >Jing Day Press
    >Calender Line Extruder
    o Validated Methods:
    >Method validation on the T9 Autotitrator and the UV7
    >Identification method validation by ATR Spectrum 2
    >Fatty acid assay method validation by GC-MS-FID
    >Plate reading validation for Vertex 311

    Client:
    >Aptar pharma


    Review of process validation reports
    Medical Devices (ISO 13485)
    Support: ASTM Standards

    o Review of process validation reports
    >Review of various reports based on non-conformities from the document audit.
    >Incorporation of feedback from the document audit into the writing of new reports.
    >Review of Arcéole report while respecting audit deadlines.
    >Application of document audit non-conformities to other products

    o Type of process validation reviewed:
    >Transport
    >Stability

    Reviewed process validation reports:
    o Arcéole
    >Transport
    >Stability

    o Arcéole Multi Dose
    >Transport
    >Stability

    o MONOBLUE SafR
    >Transport
    >Stability

    o MONOBLUE NafX
    >Transport
    >Stabilité

    o MONOBLUE BCC
    >Transport
    >Stabilité

    o PFCL – Arcotane
    >Transport
    >Stabilité

    o PFCL – Arcatine
    >Transport
    >Stabilité


    Client:
    >Arcadophta
  • EFOR
    Consultant - Qualification and Validation Engineer
    PHARMACEUTICALS INDUSTRY
    August 2019 - August 2021 (2 years)
    Software Validation
    Pharmaceutical Industry (GMP) and Medical Devices (ISO 13485)
    Support: 21 CFR Part 11 – FDA / Annex 11 (computerized systems) – GMP / GAMP5

    o Writing of a computerized system validation procedure.

    o Writing of a validation plan.
    o Implementation of a Risk Analysis and its rating.
    o Writing/review of URS and FRS (Functional Requirement Specification)
    o Writing of IQ, OQ, and PQ protocols.
    o Writing and implementation of test sheets/
    o Writing of IQ, OQ, and PQ reports.
    o Implementation of a traceability matrix.
    o Writing of a final validation report.

    Type of qualified software:
    >ERP: PMI Cegid and Infor XA
    >3D Control Machine: Mesure X
    >Electronic Document Management (EDM): SharePoint

    Clients:
    >Dubourgel Medical
    >Curium pharma



    Equipment Validation and Qualification
    Pharmaceutical Industry (GMP) and Medical Devices (ISO 13485)
    Support: Annex 15 (qualification and validation) – GMP

    o Support for equipment risk rating.
    o Update of the Validation Master Plan.
    o Writing of an equipment validation procedure.

    o Writing of the validation plan.
    o Writing/review of URS.
    o Writing Risk Analysis and implementation of a rating system.
    o Writing of IQ, OQ, and PQ protocols.
    o Writing and implementation of test sheets.
    o Monitoring the execution of tests.
    o Writing of IQ, OQ, and PQ reports.
    o Writing of a final validation report.

    Type of equipment already qualified:
    > pH meter
    > Viscometer
    > Pycnometer
    > Oven
    > Calcination Furnace
    > Refractometer
    > Moving probe tester
    > Cable tester

    Clients:
    > Strand Cosmetics
    > Elpack-Pharel
    > Seqens



    Excel Sheet Validation
    Pharmaceutical Industry (GMP) and Medical Devices (ISO 13485)
    Support: 21 CFR Part 11 – FDA / Annex 11 (computerized systems) – GMP / GAMP5

    o Support for risk rating of Excel sheets.
    o Writing of an Excel sheet validation procedure.
    o Creation of an MOP (Master Operating Procedure) for Excel sheets.
    o Review and adaptation of Excel sheets.

    o Writing of Excel sheet validation plan.
    o Writing and rating of URS.
    o Writing of a protocol per Excel sheet and associated test sheets.
    o Implementation of test sheets for different Excel files.
    o Execution of associated tests.
    o Writing of a final validation report.

    Number of validated Excel sheets: 15

    Clients:
    >Bio Elpida
  • Eurofins
    Senior Technician
    PHARMACEUTICALS INDUSTRY
    September 2016 - September 2017 (1 year)
    Fontenilles, France
    Participation in several analytical projects

    o Development of analytical methods.
    o Analysis of biological samples (pre-clinical/clinical) by HPLC or UPLC
    coupled with mass spectrometry.
    o Stability study on client compounds.
    o Validation of various analytical methods.
    o Qualification and calibration of an HPLC coupled with mass spectrometry.
    o Maintenance of analytical chains used.
    o Good Laboratory Practice (GLP) environment:
    > Writing of non-conformities and deviations specific to GLP.
    > Compliance with traceability and documentation requirements during results
    formatting.
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Education

  • Master 2 in Bio-engineering with a focus on Biochemistry and Biotechnology
    Université Paul Sabatier Toulouse III
    2016
    Master 2 en Bio-ingénierie mention Biochimie et Biotechnologies
  • Bachelor's Degree in Biochemistry - Bio-engineering, Health Option
    Université Paul Sabatier Toulouse III
    2014
    Licence Biochimie - Bio-ingénierie, Option santé

Skill set (14)

Computer Systems Validation CSV
Computerized Systems Validation
Consulting
Project Management
Data Integrity
ERP
GAMP5
GMP ANNEX 11
21 CFR PART 11
GMP
GLP
ISO 13485
Risk Analysis
Document Writing

Categories