CSV and IT Project Management Consultant

Comprehensive experience as a Senior Validation Consultant in the pharmaceutical and medical devices industry (12 years)

• Enterprise project management (EPM)3 J.
• IT-Governance
• IT Service Management (ITSM)
• Regulatory Affairs Management3 J.

Last I have successfully led SAP module validation activities at a medical device company, where I managed a cross-functional team across various continents as a project leader. My analytical skills, combined with a proactive approach, enable me to efficiently tackle validation challenges at a pharmaceutical market leader, where I conducted the initial equipment validation in just 4 months.My communication and leadership skills have allowed me to successfully oversee operational change management activities, for the same pharmaceutical market leader, where I led an initial validation and 30 changes, including 2 major changes, ensuring seamless integration of all processes. Furthermore, I have a proven track record in creating and reviewing system lifecycle documentation, for example at the medical device market leader, where I independently developed the new SOP, validation plan, and report. Additionally, I actively contributed to V-model documentation by providing creation guidance, support, and conducting reviews. My commitment to quality and ability to effectively operate within a remote team make me an ideal candidate for the position offered.