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Summary

Sciences skills: Experience in Radiochemistry & Radioprotection Experience in Aseptic Manufacturing Processes QA Skills: Experience in Validation, QC and Production Knowledge in GMP’s (Eudralex, FDA, WHO, ICH,...) Knowledge in Validation (VMP, URS, IQ, OQ, PQ, Validation Life Cycle) Knowledge in specific validation strategies (Cleaning Validation & Media Fill) Specialties: Applications of GMPs in PET Radiopharmaceuticals Synthesis Radiosynthesis of [11C]PHNO, [11C]Acetate, [11C]CH3I, [18F]SFB & [18F]FDG

Experiences

Current Experience

  • QA Assistant
    Since July 2012

Past Experience

  • Qualification Validation Operator
    August 2011 --- July 2012
    Validation Coordinator for IBA MTNA in Boston and Kansas City, USA during 4 months - Coordination of the Validations (IQ, OQ, PQ, Mediafills, Bioburden, …) of 2 IBA [18F]FDG Production Facilities (1 in Kansas City and 1 in Boston – USA) to comply with FDA cGMP 21 CFR part 212 (PET Drugs cGMP) - Training of the local employees - Documents Writing (VMP, Validation Protocols, SOP’s…) Qualification Validation Operator for IBA Louvain-La-Neuve during 8 months - Validation protocols redaction for IBA customers (GC, HPLC, …) - Basic GMP & Validation training for IBA Molecular Equipment Sales employees - Review & development of HPLC methods for IBA’s PET tracers Quality Control

  • PET Chemist
    May 2009 --- November 2011
    Day to day production of new and already established PET Radiopharmaceuticals ([11C] and [18F] tracers) Redaction and Implementation of validation protocols Operation of various automated radiochemistry equipments (Eckert & Ziegler, GE, Siemens, Synthra) Development, implementation and validation of methods for labeling with PET isotopes Management of laboratory equipment (including maintenance, troubleshooting and repair) Development of HPLC methods for PET radiopharmaceuticals Documenting production records to ensure compliance with cGMP

  • QC & Production Technician
    September 2006 --- May 2009
    Validations for QC and Production Daily Tests on the [18F]FDG: TLC, HPLC, pH, Gamma spectrometer, GC and environmental monitoring Maintenance of the QC machines Updating of the QC and production SOP’s QC trends analyses Management of the QC and Production stocks [18F]FDG Synthesis Operating the cyclotron Developing and validating various analytical methods Maintaining documentation practices within the laboratory Working in an aseptic environment and with radioactivity Cleaning, sterilizing, and maintaining laboratory equipment and work areas Ensuring the laboratory is well stocked and resourced

  • Production Operator in Bulk Stream Department
    October 2005 --- April 2006
    Work in aseptic conditions Using of sterilization and decontamination autoclaves Cleaning and sterilization of the material for the sterile area Pharmaceutical cleaning of the production areas Weekly fluid sampling of the Deionised Water and Water For Injection loops (Sterility, Endotoxin, TOC and Conductivity) Reception and management of the material for the stock area

  • Validation Support Technician
    July 2005 --- September 2005
    Validation sampling of water loops (Sterility, Endotoxin, TOC and Conductivity) and gases

Knowledge

LinkedIn Assessment :
GMPPharmaceutical IndustryValidationGood Laboratory Practice (GLP)HPLCFDAQuality Assurance (QA)gas chromatographyAseptic ProcessingCleaning ValidationQuality Control (QC)Aseptic TechniquesRegulatory RequirementsLaboratorySOP authoringSOPPharmaceutics

Education

  • (2 Days course) in Cleaning Validation from European Compliance Academy in 2011
  • 2 Days course in The New FDA/EU Approach to Process Validation from European Compliance Academy in 2011
  • 3 Days course in Positron Emission Tomography Technology and Application from Kings College London in 2011
  • Radioprotection Supervisor (2 days course with assessment) in Radiation Protection Supervisor – Certificate of achievement from Suffolk Radiation Technical Services Limited in 2009
  • Bachelor in Biochemistry applied to Cosmetology from Institut Rogier Lambion in 2007
  • Graduated in Chemistry from College Sainte Gertrude - Nivelles in 2000

Area / Region

Seneffe, Belgique

Others

Driving License
  • No