Experience

District09

• Belgium
• IT Services and IT Consulting
• 100 - 200 Employee

• Projectmanager

  • Jan 2021 - Present

  Gent, Vlaanderen, België



Digipolis

• Belgium
• IT Services and IT Consulting
• 100 - 200 Employee

• Project Leider Applicatie Ontwikkeling

  • Mar 2017 - Dec 2020

  Gent Area, Belgium



BARC Global Central Laboratory

• Test Team Lead / Validation Manager

  • 2014 - 2016

  Test Team Lead: - Planning of testing resources - Coordination of the test strategy in accordance to agile development - Day to day follow up of the team towards qualitative and consistent testing - Manage the performance and competence of the team members - Motivate team members in pro-active and clear communication - Escalate impediments pro-actively and help provide solutions - Identify risks and problems and follow up the resolution Validation Manager: -… Show more Test Team Lead: - Planning of testing resources - Coordination of the test strategy in accordance to agile development - Day to day follow up of the team towards qualitative and consistent testing - Manage the performance and competence of the team members - Motivate team members in pro-active and clear communication - Escalate impediments pro-actively and help provide solutions - Identify risks and problems and follow up the resolution Validation Manager: - Create or participate in the analysis of user requirement specifications - Create or participate in the analysis of functional / design specifications - Perform system and project risk analysis - Coordinate user acceptance testing - Coordinate incident management handling - Coordinate change management handling - Data security, integrity, confidentiality and reliability - Manage the validation file for compliance towards customer and regulatory audits - Validation plans and reports Show less



BARC Global Central Laboratory

• IT Project Manager / Validation Manager

  • 2012 - 2013

  Responsibilities Project Manager - Assure the project is completed within timelines, budget, schedule, and according to the required specifications; - Define milestones and detailed tasks in Gantt chart including timelines and required resources - Monitor the progress of each individual task by project meetings and individual follow-up - Pro-actively identify project risks and suggest solutions - Facilitate cross-functional team communications (and external suppliers) for… Show more Responsibilities Project Manager - Assure the project is completed within timelines, budget, schedule, and according to the required specifications; - Define milestones and detailed tasks in Gantt chart including timelines and required resources - Monitor the progress of each individual task by project meetings and individual follow-up - Pro-actively identify project risks and suggest solutions - Facilitate cross-functional team communications (and external suppliers) for technical set-up and toward timely achievement of the project objectives - Coordinate communication between business and IT to establish optimal to-be scenario - Coordinate test phase - Coordinate and supply communication and training of changes to end-users

• Validation Manager

  • Apr 2011 - Sep 2012

  - Create or participate in the analysis of user requirement specifications - Create or participate in the analysis of functional / design specifications - Perform system and project risk analysis - Coordinate user acceptance testing - Coordinate incident management handling - Coordinate change management handling - Data security, integrity, confidentiality and reliability - Manage the validation file for compliance towards customer and regulatory audits - Validation… Show more - Create or participate in the analysis of user requirement specifications - Create or participate in the analysis of functional / design specifications - Perform system and project risk analysis - Coordinate user acceptance testing - Coordinate incident management handling - Coordinate change management handling - Data security, integrity, confidentiality and reliability - Manage the validation file for compliance towards customer and regulatory audits - Validation plans and reports



Fujirebio Europe

• Belgium
• Medical Device
• 100 - 200 Employee

• Validation Engineer

  • 2004 - Mar 2011

  Ghent - Review of all validation documents and validation approach. - Developing and implementing a global SOP framework concerning validation and keeping it up to date with new trends in the industry (such as GAMP, FDA cGMP, ICH, ASTM, GHTF, ISPE, PIC/S GMP, EU cGMP’s (eudralex), GCP, EN and ISO). - Training concerning system/method validation and data integrity/security (21 CFR Part 11). - Giving guidance to the system matter experts/owners in regard to the different validation… Show more - Review of all validation documents and validation approach. - Developing and implementing a global SOP framework concerning validation and keeping it up to date with new trends in the industry (such as GAMP, FDA cGMP, ICH, ASTM, GHTF, ISPE, PIC/S GMP, EU cGMP’s (eudralex), GCP, EN and ISO). - Training concerning system/method validation and data integrity/security (21 CFR Part 11). - Giving guidance to the system matter experts/owners in regard to the different validation categories: software systems, equipment, methods, process and IT Infrastructure. - Organize, plan and follow-up of validation activities. - Performing internal audits. Implementation of validation projects: - Introduction of a Risk Based Validation approach - Validation efficiency improvement - Introduction of validation principles within a company - Introduction of a Method Validation methodology Show less