Experience

College ter Beoordeling van Geneesmiddelen

• Netherlands
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Quality Assessor

  • Jan 2020 - Present



Stichting Roseland Ethiopia

• Holeta Town, Ethiopia

• Chairman Stichting Roseland

  • Feb 2010 - Present

  Founder of non-profit organization Roseland / Rose Land Child Development Organization in Holeta Town Ethiopia to support the poorest of the poor children and their families (see: www.stichtingroseland.com) Founder of non-profit organization Roseland / Rose Land Child Development Organization in Holeta Town Ethiopia to support the poorest of the poor children and their families (see: www.stichtingroseland.com)



Sanquin

• Netherlands
• Hospitals and Health Care
• 700 & Above Employee

• Manager QC Projects

  • Feb 2015 - Dec 2019

  In this position I coached a team of 20 QC experts. The team was responsible for implementation and improvement of efficient QC and QA processes and Quality Systems related to inspection readiness, bio analytical and microbiological method validation, laboratory equipment validation including cold chain and CSV, data integrity, documentation system and training, supplier assessments and material reviews, CNF processing, Trackwise change, deviation and CAPA management, CMO management and CMO… Show more In this position I coached a team of 20 QC experts. The team was responsible for implementation and improvement of efficient QC and QA processes and Quality Systems related to inspection readiness, bio analytical and microbiological method validation, laboratory equipment validation including cold chain and CSV, data integrity, documentation system and training, supplier assessments and material reviews, CNF processing, Trackwise change, deviation and CAPA management, CMO management and CMO related quality projects, transfers, Service Level and Quality agreements, risk based GAP remediation projects related to compliance issues and regulatory affairs support and filing strategies Show less In this position I coached a team of 20 QC experts. The team was responsible for implementation and improvement of efficient QC and QA processes and Quality Systems related to inspection readiness, bio analytical and microbiological method validation, laboratory equipment validation including cold chain and CSV, data integrity, documentation system and training, supplier assessments and material reviews, CNF processing, Trackwise change, deviation and CAPA management, CMO management and CMO… Show more In this position I coached a team of 20 QC experts. The team was responsible for implementation and improvement of efficient QC and QA processes and Quality Systems related to inspection readiness, bio analytical and microbiological method validation, laboratory equipment validation including cold chain and CSV, data integrity, documentation system and training, supplier assessments and material reviews, CNF processing, Trackwise change, deviation and CAPA management, CMO management and CMO related quality projects, transfers, Service Level and Quality agreements, risk based GAP remediation projects related to compliance issues and regulatory affairs support and filing strategies Show less



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Manager TPE Commercial Quality

  • May 2014 - Feb 2015

  European Quality Projects Management

• Sr. Specialist R&D

  • May 2012 - Apr 2014

  Quality issues related to R&D processes Perform Risk Assessments Track Wise Manager Validation of Laboratory (Computerised) Systems in accordance with GAMP 5 and Part 11

• Director Analytical Development Generic Research &Development

  • Dec 2007 - May 2012

  • Responsible for development and validation of Analytical Methods under GMP conditions • Coach a team of researchers • Perform Risk Assessments related to Analytical Development and R&D processes. • Responsible for preparation and review of the chemical pharmaceutical part of the registration file (first-doc, Wisdom) for all markets including Japan.

• Manager Analytical Development Generic Research & Development

  • Jan 2005 - Dec 2007

• Project Manager Analytical Development Generic Research & Development

  • May 2001 - Jan 2005