Hoogstraten, Flemish Region, Belgium
I am passionate about software quality and have more than 25 years experience validating systems at Janssen (clinical data systems) and Sanofi (production systems). My validation activity started in 1994 when Janssen's global clinical data systems needed to be validated. That project gave so much energy that I decided to switch my career in that direction. I worked on several projects for which I discussed the validation strategy with Quality Assurance, documented the approach, coached and coordinated the validation team and described the test and validation results. Over the years I became expert in software tools to digitalize the validation process such as HP ALM, TrackWise, Kneat Gx. I am proud of several validation projects that were completed successfully, but the most energy I get is when the validation knowledge of the team increased during the project. In my next role I would like to use my skills and quality passion in a new environment - to guarantee the quality of newly developed systems or support the implementation of software; - to (improve) the digitalization of the validation process with digital tools such as HP ALM and Kneat Gx. ☛ Any question? Contact me: ✉ [email protected] ✆ +32 474 84 27 38
TASKS • Configuration and validation of the Kneat paperless validation software for Sanofi Geel • Validation of computer systems
TASKS • Orchestrated development teams on compliance approach (SLDC) • Delivered coaching to testers for test execution and preparation. • Authored complex SLDC and procedural documents. • Led internal/external audit and coaching on trial validation. • Served as Corrective & Preventive Actions (CAPA) Champion. • Organized validation approach and planned timelines for validation deliverables. • Liaised all validation tasks and updated planning to ensure on-time delivery. • Completed all validation tasks in a timely manner. SOME REALISATIONS Efficient procedure for tool validation (2019) • Introduced risk based validation approach with no QA involvement for low risk tools. • Produced spreadsheet to determine the risk level for all tools - less then 25% high risk tools. • Increased quality and documentation in a single pace. SAS DD for Data Analytics & Reporting (2014-2016) • Streamlined validated systems for statistical analysis aligned with data management. • Achieved zero bugs reported and no major findings in the internal system audit.
TASKS • Spearheaded development programming teams on compliance approach. • Delivered coaching to testers for test execution and preparation. • Wrote complex SDLC documents and procedural documents. • Streamlined validation of internal servers and statistical systems. • Produced action plan for timely validation documents and QA approaches. • Supported internal/external audits. • Delivered technical support on EU-based users of Biostatistics & Programming.
TASKS • Orchestrated a group of data management analysts to support data review to streamlined clinical databases and statistical analysis that support the statistician in the study of clinical trials. • Served as a member of the implementation team of a global data management/statistical programming system EXAMPLE REALISATION - ARROW 1.0 Implementation • Developed validation template documents for internal developed system. • Trained and coached the implementation on validation tasks. • Successfully delivered the validation of Arrow 1.0 in Jun 1996, the first global system implementing a one-way process to clinical trial data.
Managing the company's computer environment, developing applications using RPG