Resume/CV: Ing. Leo van den Besselaar Personal Details Title Ing. Male Surname or family name van den Besselaar First or given name Leo (Leonardus Adrianus Maria) Nationality Dutch Date of Birth June 12, 1963 Home or correspondence address Street and number : Van Leeuwenhoeklaan 16 Postcode : 5252 CC City: Vlijmen Country : The Netherlands Tel. No. : +31(0)735117891 Mobile Phone no. : +31(0)653796401 Email: leo.besselaar@lbqconsultancy.nl Business details Part-time job (50%) TüV Rheinland Name of Organisation TüV Rheinland Nederland BV Address PO Box 541 Postcode : 7300 AM City: Apeldoorn Country: The Netherlands Tel. no. : +31(0)888887888 Fax no. : +31(0)888887879 Mobile Phone no. : +31(0)653324551 Email: Leo.van.den.Besselaar@nl.tuv.com Part-time job, my own 1 st consultancy office Name of Organisation LBQ Address Street and number: Van Leeuwenhoeklaan 16 Postcode: 5252 CC City: Vlijmen Country: The Netherlands Tel. no. : +31(0)735183530 Mobile Phone no. : +31(0)653796401 Email: leo.besselaar@lbqconsultancy.nl Part-time job, my own 2 nd consultancy office Name of Organisation GMP TopConsult BV Address Street and number: Van Leeuwenhoeklaan 16 Postcode: 5252 CC City: Vlijmen Country: The Netherlands Tel. no. : +31(0)735183530 Mobile Phone no. : +31(0)653796401 Email: leo.besselaar@gmptopconsult.nl CV-LvdB-01-01-2011 Page 1 of 6
Academic and Technical Qualifications Year Award Course Qualifying authority 1981-1983 Yes Intermediate Vocational Education Analytical Chemistry 1986-1990 Yes Higher Vocational Education Analytical Chemistry High School Eindhoven High School West Brabant 1999 Yes Total Quality Management High School West Brabant (Auditor) Year Award Course Qualifying authority 1998 Yes Internal Auditing I Dutch Normalisation Institute (NEN) 1998 Yes Internal Auditing II Dutch Normalisation Institute (NEN) 1998 Yes GMP Compliance auditing Pharmaceutical Compliance Associates, Stockholm 1999 Yes Internal auditing ISO 9001 High School West Brabant 2001 Yes ISO 9001:2000 Series Auditor / Lead Auditor Course BVQI 2003 Yes GMP Feed PDV 2003-2006 Yes IRCA QMS Lead Auditor IRCA, Registration number 1183697 2008 NA Lean Six Sigma TNO Management Consultants 2008 Yes Lead Auditor IKM 3000, complaint management Foundation IKM 3000 2008 Yes 3 Day GMP Conference Pharmatech 2009 NA Chain Management TNO Management Consultants 2010 Yes Integration OHSAS 18001 and ISO 9001 Dutch Normalisation Institute (NEN) 2010 Yes 3 Day GMP Conference Pharmatech 2010 Yes Social Responsibility ISO 26000 Dutch Normalisation Institute (NEN) CV-LvdB-01-01-2011 Page 2 of 6
Work Experience Year Job Title Company 1985-1988 Chemical Analyst Diosynth BV (Akzo Nobel) 1988-1992 Team leader Analytical Methodology Diosynth BV (Akzo Nobel) 1992-1998 QC Manager Diosynth BV (Akzo Nobel) 1998-1999 Quality Auditor Diosynth BV (Akzo Nobel) 1999-2002 Quality System Manager Diosynth BV (Akzo Nobel) 2002-2004 International Quality System Manager Diosynth BV (Akzo Nobel) 2004-2005 Global QHSE Manager API-manufacturing Organon NV (Akzo Nobel) 2005-2006 Interim Business Unit Manager TNO Certification BV 2006-2008 Lead Auditor System Certification TNO Certification BV 2009- to day Lead Auditor System Certification TüV Rheinland Nederland Work Experience as consultant Year Job Title Company 2003-2005 Certification Auditor ISO-9001, ISO-22000, HACCP, BRC, GMP-Feedsafety TNO Certification BV 2004-2005 Certification Auditor GMP-Feedsafety KIWA Certification 2005-2007 Supplier auditor pharmaceutical industry SQA Services (USA) 2003- to-day Consultant Quality Management & Audits LBQ 2005- to day Managing Director / Consultant GMP TopConsult BV 2005- to day Trainer Internal Auditing NEN 2008- to day Trainer Laboratory Management Avans High School Specific Auditing Experience - Internal audits I performed around the 40 internal audits within Diosynth BV covering all kinds of departments and activities. - I performed around the 100 supplier audits covering all kinds of products and services: contract laboratories, API-manufacturers, solvents, chemicals, equipment. - Guidance of customer audits For Diosynth BV I guided around the 50 customer audits for customers buying Biochemical, Chemical and Biotechnological API s. - Guidance of GMP inspections For Diosynth BV I guided 15 GMP inspections: - FDA inspections within Diosynth BV in the Netherlands and Diosynth SA in France. - MHRA inspection within Diosynth Ltd in Scotland. - Inspections of the Dutch authorities within Diosynth BV in the Netherlands. - Certification Audits - I performed around the 250 ISO-9001 / ISO-22000 / HACCP / BRC audits on behalf of TNO-Certification and TüV Rheinland Nederland BV. - I performed around the 70 GMP-Feedsafety audits on behalf of KIWA-Certification within the Feed-industry. CV-LvdB-01-01-2011 Page 3 of 6
References LBQ / GMP TopConsult Company Abalco Service Akzo Nobel Chemicals Avans High School Banner Pharmacaps Budelpack CML Europe FAMAR Nederland GlaxoSmithKline Janssen Animal Health Innogenetics Magma IT Solutions MSD Mondial Pack NEN Nutrilab Organon NV Pharma Consulting & Industries Pharmaceutical Services Pharmatech Peter Greven Schering-Plough Schouten SQA Services Van de Wiel Beveiliging Van Loosbroek Farma Consult Van Meeuwen Activity Internal audits / training / internal audits Internal audits / internal audits Interim Management CV-LvdB-01-01-2011 Page 4 of 6
An overview of the performed Supplier Audits Company Country Product Chimica Sintetica Spain Active Pharmaceutical Ingredients Diosynth BR Brazil Active Pharmaceutical Ingredients Diosynth Inc USA Active Pharmaceutical Ingredients Diosynth LTD Scotland Active Pharmaceutical Ingredients Diosynth SA France Active Pharmaceutical Ingredients Euticals S.p.A. Italy Active Pharmaceutical Ingredients Finaf-92 Spain Active Pharmaceutical Ingredients Heumann Germany Active Pharmaceutical Ingredients Moehs SA Spain Active Pharmaceutical Ingredients Sanofi-Synthelabo France Active Pharmaceutical Ingredients SelocFrance France Active Pharmaceutical Ingredients Sifa Ltd Ireland Active Pharmaceutical Ingredients Sun Pharmaceuticals India Active Pharmaceutical Ingredients Bruno Bock Germany Acids Dex Plastomers The Netherlands Polymers DSM/DSI The Netherlands Pharmaceutical Intermediates Life Technologies Scotland Cell Cultures Linde Gas Benelux The Netherlands Liquid Gasses Miavit GmbH Germany Food & Feed Merck KGaA Germany Chemicals Protexin England Food & Feed PVS Chemicals Belgium Acids Analytico The Netherlands Contract Laboratory MTL Scotland Contract Laboratory Organon Teknika The Netherlands Contract Laboratory Saybolt Nederland BV The Netherlands Contract Laboratory SGS The Netherlands Contract Laboratory BASF Germany Solvents DOW Deutschland GmbH Germany Solvents Helm AG Germany Solvents Heybroek The Netherlands Solvents Univar Belgium Solvents Methanex Europe Belgium Solvents Methanor The Netherlands Solvents Alloga The Netherlands Storage & Distribution (Pharmaceuticals) Caldic Europoort BV The Netherlands Storage & Distribution (Solvents) Organon The Netherlands Storage & Distribution (Pharmaceuticals) Vopak The Netherlands Storage & Distribution (Solvents) ATMI Packaging Belgium Packaging Materials Bünder Glass Germany Injection Cartridges Foxboro The Netherlands Computer Systems PCLD Deventer The Netherlands Contract Manufacturing Octavius Hunt England Smoke Generators Pierre Guerin France Process Equipment CV-LvdB-01-01-2011 Page 5 of 6
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