Dirk van Gorp

Background

About Dirk van Gorp

Experienced in all aspects of operating a small consulting business for regulatory and compliance support to the (bio)pharmaceutical industry. • Designing, implementing, managing and executing instrument lifecycle management programs in a GxP regulated environment. • International experience working and living in Europe (Belgium) and the USA (New Jersey). • Filled lead roles in pharmaceutical research and development, Validation/Qualification, Quality and Compliance Management. • Strong working knowledge of Pharmaceutical regulations and guidelines such as cGMP, GLP, ICH, USP, GAMP, 21 CFR part 11, 58, 210, 211 and 820. • Highly organized project manager, skilled at problem solving, planning and coordinating multiple projects simultaneously in a timely and cost-effective manner. Proficient with the use of PM tools (e.g. Kanban, Trello, GTD) • Experienced in managing and performing Events, Deviations, CAPAs, conducting root cause analysis using a variety of techniques (DMAIC, 5 why’s, Is – Is not, etc). • Highly involved in designing, implementing and improving QMS elements. • Designing, implementing, following up and reporting of KPIs and metrics to create full transparency of processes and to initiate continuous improvement projects. • Experienced in performing Risk Assessment, Management and Mitigation, including FMEA. • Full Validation Life Cycle experience including Change Controls, Protocol templates, Risk Assessments, Validation Plans, IQ, OQ, PQ, Traceability Matrix, and Validation Reports. • Demonstrated success in building and maintaining excellent working relationships and partnerships with client groups, Quality Assurance, other internal service providers (e.g. IT, Maintenance and Engineering, EHS) and third-party vendors. • Direct management and supervision of validation staff and third-party vendors. • Computer Skills: Proficient in MS Office as well as various specific software programs and customized systems (e.g. Trackwise, DocSpace, eLN).