January 2017 - at Present
Hired to develop quality standards in the Belgium operations, I am accountable for the development of procedures and resolutions of CAPA. I was promoted to the global quality organization as part of the team managing regulatory inspections. I gained invaluable experiences in understanding pharmaceutical quality systems and culture. - Manage FDA inspection logistics, an opportunity that provided me with a good understanding of GMP processes and regulatory requirements. - Accountable to put together CAPA plans, addressing regulatory inspection remarks. In this role, I conducted Root Cause Analysis (RCA) workshops with cross-functional teams, aligned stakeholders and, ensure updated documentations. -Provide support to pre-approval inspections for a new vaccine.
January 2016 - January 2017
-Spearheaded procedures’ development for primary and secondary operations including the deployment of training materials. -Implemented global GSK quality system to define and drive CAPA resolution in facilities and maintenance. In this role, I communicate effectively in a bilingual environment with global and local teams. -Developed performance KPI’s and visual trackers to drive performance and anticipate issues during CAPA resolution. -Communicated with all levels and functions in the engineering department and across various production units to drive actions.
January 2015 - September 2015
Developed process parameters of an innovative molecular biology stem cell technology based on genetic vector. The optimized process resulted in a yield improvement of 50% and a 30 % reduction in production cycle time.
October 2014 - February 2015
Report current and future therapeutically targets in the chronic inflammation of HIV in literature for the design of mass spectrometry experiment.
June 2014 - August 2014
Pilot production of GMO poplar line to study a family of genes and the link to nematode infection. I built a bank of genetic vectors, conducted cloning, transfected poplar tree and conducted statistical analysis between RNA and protein using R statistics software.
Master in Biotechnology and life science
2010 - 2015 (5 years)
Knowledge and keywords