Resumé

  • December 2005-Present: SpeQ Reports, director/consultant
    Several companies:

    • Process Validation Protocols and (Summary) Reports
    • Cleaning Validation Protocols and (Summary) Reports
    • Cleaning validation – determination/calculation of residue specifications
    • (International) Technology transfer
    • PQR process optimization
    • QMS / DMS
    • QA CAPA handling
    • Equipment qualification (IOQ) documents
    • Process Development Reports
    • Gap assessments
    • Risk assessments in relation to Cleaning and Process
    • Specifications / SOP’s
    • Module 3 CMC documentation
    • Waste Management Policies
    • Analytical Validation Reports
    • Spreadsheet Development and Validation
    • Implementation of employee training system
    • Manager production department
  • December 2002-December 2005:
    Solvay Pharmaceuticals BV in Olst, the Netherlands:

    • prepare, perform and finish validations and verifications of the production process of medicinal tablets, including making protocols, taking samples, performing analyses and writing the reports
    • international technology transfer of production processes to another production site
    • troubleshooting of the production process
    • scale up and adjustment of parts of the process of producing medicinal products
    • working with GMP-rules
  • June 1999-December 2002:
    CAS / Selact BV in Groningen, the Netherlands:

    • synthesis of fine chemicals
    • development and control of consumer products
    • screening of catalysts
    • development of analysis methods
    • performing analyses
  • April 1998-April 1999: 
    Intersynth BV in Groningen, the Netherlands:

    • synthesis of chemicals
    • scale up of synthesis of chemicals
    • characterisation of chemicals
  • 1997-1998:
    practical assistant / research employee at the Rijksuniversiteit Groningen, the Netherlands for organic synthesis practicals for first and second year chemistry and pharmacy students (4 x 4 weeks).
  • 1994-1997:
    Chemistry study (Organic Chemistry) at the Rijksuniversiteit Groningen, the Netherlands. Graduated in August 1997.
  • 1990-1994:
    H.L.O. (Higher Laboratory Education, Analytic/Organic Chemistry) at the Rijkshogeschool Groningen, Section Nature & Technique, the Netherlands. Graduated in 1994.
  • 1986-1990: 
    M.L.O. (Medium Laboratory Education, Chemistry) at the Analistenschool Groningen, the Netherlands. Graduated in 1990.
  • 1995-1997:
    during Organic Chemistry study: ‘Model systems for iron containing oxidation enzymes. Towards enantioselective oxidation.’ R.u. Groningen, the Netherlands. Contact Prof. Dr. B.L. Feringa.
  • 1993-1994:
    during HLO: ‘Lineaire azo-polymeren voor “colon-specific drug delivery”. Synthese en eigenschappen.’ K.U. Leuven, Belgium. Contacts Prof. Dr. C. Samyn and Dr. G. van den Mooter.
  • 1989-1990:
    during MLO: AKZO-PQ-Silica in Winschoten, the Netherlands, quality control of waterglass. Contact dhr. G. Castellani.
  • Article about the research performed during HLO internship (1993-1994):
    Van den Mooter, G., Offringa, M., Kalala, W., Samyn, C., Kinget, R.; Synthesis and evaluation of new linear azo polymers for colonic targeting; 
    ST.P. Pharma Sci     1995; 5: 36-40 (now called Journal of Drug Delivery Science and Technology).