22/05/2016
Proudly, we share with you our new work reference written by Laszlo Rethelyi
Head of Corporate Project Management Office at EGIS Pharmaceuticals PLC
He wrote about the services QA-TI provided:
"The building up of the new R&D Center for HP API & DP development (building-3 project) and the enlargement of the Scale-up facility (building-7 project) (with value of 6.5 mill Eur) were supported by EU and governmental founds and aimed to be finished for the centennial establishment celebrations of EGIS. Katalin was responsible for the GMP compliance of the new facilities, in general, with emphasis on building-3. She fulfilled the following tasks in the project team: - participation in the selection of the suppliers of the isolators, establishing URS-s, qualification of designs, - review and comment on the different plans/drawings of engineering disciplines in relation to the construction of the building, communicating GMP requirements, establishing URS-s, - performing weekly tours of the facility, commenting / supporting ongoing works from QA point of view, - review and approval of all IQ / OQ, qualification / verification / validation protocols and reports related to the new equipment / new systems / new facility,. Katalin proactively initiated four important, quality enhancing changes during the design qualification and the construction - with good time keeping. The project was successfully closed within the predefined 18 months time-frame. The NIP approved the use of the new building for the planned R&D activities without critical or major observations. She was a very active and invaluable asset of our operative team. During her work with different departments of our directorate she showed her cross-functional communication skills and high level interdisciplinary knowledge on diverse fields of engineering. She presented the quality objectives on a creditable manner - with the eyes of the engineers. We appreciated her constructive initiations, which were helping us to deliver our project on time and in high quality. "
