Experience

Rescop

• Netherlands
• IT Services and IT Consulting
• 1 - 100 Employee

• Principal Consultant

  • May 2022 - Present

• Senior CSV (Computerized System Validation) Consultant

  • Sep 2017 - May 2022

  Manage IT (validation) projects: • Lead projects • Generate and monitor project planning • Manages and monitors budget • Ensures plan and procedures are followed • Identify and manage project risks • Manage communication to stakeholders • Advise/decide on required validation resources • Participate in supplier assessment and selection • Writing Validation Master Plan/Report for complex Computerized Systems



Cardialysis B.V.

• Netherlands
• Research Services
• 1 - 100 Employee

• ICT Manager

  • Jul 1997 - Sep 2017

  I have 25 years of experience in all areas of IT (system development, business analyst, server and network administration, IT manager, IT project management) within GCP environments / life sciences, I am extremely familiar with all validation activities required for implementing processes and/or computerized systems (CSV-validation). During these years, I have managed several internal projects (planning, financial budget, resources, risk mitigation, supplier audits and assessments… Show more I have 25 years of experience in all areas of IT (system development, business analyst, server and network administration, IT manager, IT project management) within GCP environments / life sciences, I am extremely familiar with all validation activities required for implementing processes and/or computerized systems (CSV-validation). During these years, I have managed several internal projects (planning, financial budget, resources, risk mitigation, supplier audits and assessments, etc.) and have acquired profound knowledge in several processes and systems in the areas of: Electronic Data Capture (EDC), clinical trial management (e.g. CTMS), clinical event adjudication (CEC), safety (ArisG), system integrations, 21CFR11 part 11, GAMP5, ICH-GCP, ACDM/PSI. As a department manager, I have many years of experience in people management (coaching, delegating, motivating, defining and managing competences, assessments) to support colleagues in their personal development and in line with the company’s business strategy and objectives.

• System Administrator / Developer

  • May 1992 - Jul 1997