Experience

Astellas Pharma Europe

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manager Technology & Data Quality Assurance

  • Jun 2021 - Present



MSD Netherlands

• Netherlands
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Qualification Engineer (temporarily on assignment)

  • Jan 2021 - Jun 2021

• Quality Specialist - QA-IT

  • May 2019 - Jun 2021

  Quality Assurance responsabilities in a GMP environment with a focus on Computerized System Validation and Data Integrity.

• Associate Specialist Quality Assurance - QA Systems

  • Oct 2018 - May 2019

  Quality Assurance responsabilities related to Computerized System Validation in a GMP environment.



Astellas Pharma Europe

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientist and Quality (GLP) Coordinator

  • Jan 2012 - Oct 2018

  Bioanalysis- Europe (BA-EU) departmentGood Laboratory Practice (GLP) coördinator;- Coördinate GLP activities in the BA-EU laboratory.- Maintain BA-EU Quality System; coordinate periodic review, writing and updating quality documents - Act as intermediate between the BA-EU laboratory and the Quality Assurance (GLP-QA) department- Involved in the biannual GLP inspection by IGZComputer System Validation (CSV)- Member of the BA-EU System Validation team- Execute and support CSV activities of laboratory information (e.g. LIMS, LMS, HPRM, excel sheets) and laboratory equipment (e.g. LC-MS/MS, MSD, RT-PCR)- Execute periodic review of laboratory systemsSubject Matter Expert (SME) for the BA-EU Learning Management System (LMS) (SuccessFactors)Subject Matter Expert BA-EU Document Management System (Documentum)Subject Matter Expert BA-EU Records Management System (HP Records Manager)Subject Matter Expert Watson LIMS - Configuration and upgrade of Watson LIMS in a GLP environmentStudy Director PK studies- Responsible for the execution of internal bioanalytical (validation) studies- Writing of bioanalytical study plans and reports Show less

• Principal Technician

  • Apr 2002 - Jan 2012

  Bioanalysis-Europe (BA-EU) departmentStudy Director PK studies - Responsible for the execution of internal bioanalytical (validation) studies - Writing of bioanalytical study plans and reports - Executing bioanalytical method set-up and validation using LC-MS/MSComputer System Validation (CSV) - Member of the BA-EU System Validation team - Involved in the CSV activities of laboratory systems (equipment, LIMS, excel sheets)Subject Matter Expert Watson LIMS - Implementation, configuration and upgrade of Watson LIMS in a GLP environment Show less



National Institute for Public Health and the Environment (RIVM)

• Study Leader

  • 1994 - 2002



Byk Gulden, Zwanenburg

• Zwanenburg

• QC analist

  • 1992 - 1994