Meria Lambregts

Experience

• 

  Organon

  Jul 1990 - Jul 2009

  Outsourcing of manufacturing & packaging activities for clinical trials Phase II and III. The Senoir MIS Officer is responsible for sourcing comparator products for clinical trials and writing manufacturing records for production of solid & non-solid supplies according to GMP guidlines. Managing the GMP-documentation group of approx 5 persons. The documentation group is responsible for control, archiving & distribution of GMP documents such as SOP's, logbooks, training record etc. Responsible for management of the SOP system within Department of Dispensing Services & Control. Managing the CP-group of approx. 5 persons who are responsible for analysing samples of drug product for clinical studies and reporting of the results. Responsible for the planning of analysis and reviewing the analytical testresults performed by the technicians. Managing the IPA-group of approx. 3 persons who are responsible for analysing samples of drug product for tox studies and reporting of the results. Responsible for the planning of analysis and reviewing the analytical testresults performed by the technicians. Optimalization chromatographic analysis methods for the determination of analytical samples for clinical trials. Writing study protocols and planning development- and stability studies; Reporting study results in study files, Optimalization chromatographic analysis methods. Routine and method development activities on HPLC and GC analyses of stability samples.

  • Senior Outsourcing Officer, Logistic Services, Investigational Products Supply

    Jul 2004 - Jul 2009

  • Senior MIS Officer, Logistic Servies, Investigational Products Supply

    Jul 2003 - Jul 2004

  • Teamleader GMP-Documentation Group, Quality Control, Investigational Products Supply

    Jul 2000 - Jul 2003

  • Coordinator Standard Operation Procedure, Department of Dispensing Services & Control

    Jul 1997 - Jul 2000

  • Teamleader CP-Group, Analytical Group, Department of Dispensing Sevices & Control

    Jul 1994 - Jul 1997

  • Teamleader IPA-Group, Analytical Group, Department of Dispensing Sevices & Control

    Jul 1993 - Jul 1994

  • Technician, Analytical Group, Department of Pharmaceutics

    Jul 1991 - Jul 1993

  • Laboratory Technician, Section Solid Dosage Forms, Department of Pharmaceutics

    Jul 1990 - Jul 1991
• 

  Schering-Plough Research Institute

  Jul 2009 - Jul 2011

  Vendor Manager, External Networks, Global Clinical Supply at SP

  Vendor Manager, External Network, is responsible for management of the packaging, labeling and distribution of Clinical Supplies outsourced at Contract Research Organizations. Work with external & internal stakeholders to ensure the clinial materials will be produced with good quality & on time.

• 

  Merck

  Jul 2011 - now

  Vendor Manager, External Networks, Global Clinical Supply at MSD

  Vendor Manager, External Network, is responsible for management of the packaging, labeling and distribution of Clinical Supplies outsourced at Contract Research Organizations. Work with external & internal stakeholders to ensure the clinial materials will be produced with good quality & on time.