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Deepika Voona
Clinical Project Change Control Co-ordinator @Novartis
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WORK HISTORY
Clinical Project Change Control Co-ordinator @Novartis
Successfully managed major site level change requests and/or projects to launch a new clinical phase study, geographical expansion of existing Phase I and Phase II studies to more countries and demonstrated the ability to manage several changes parallelly with conflicting timelines in a fast paced environment. Authored and managed more than 20 change controls from initiation to execution which included but not limited to Process improvements, manufacturing efficiency, business continuity, warehouse expansion, Materials introduction, Dewar introduction and optimization etc, This also entails that requests progress with proper governance in terms of compliance and Health Authority requirements. Presented and gathered feedback from the CCRB to ensure decisions are made in a timely manner and responsible for day-to-day accurate execution of the change management process. Managed and successfully implemented a challenging project to roll out a new higher dose for PHE Phase II. Managed to effectively collaborate with internal site incumbents, Cell chain team, Global Clinical supply, and clinical team so that High Dose material numbers gets activated in the cell chain after receiving both HA and EC/IRB approvals for a given country and a site. Played an important role in developing a creative compliant solution about transparency of flow of information especially with Health Authority & EC/IRB approvals within EHPP site, as well with other SPOCs, CMOs and internal sites. Maintained vertical and horizontal communications on Approval status. Responsible for rolling out a new process for the first time on site to Onboard French Hangtag Label to meet Health Canada requirements, the final product label to be available both in English and French. Collaborated effectively within site (involving various line units) to implement all activities related to new process such as qualifying supplier, procuring, ordering, receiving, storing, and issuing the hangtag labels.
EDUCATION
Montclair State University
Master's degree, Molecular Biology
SKILLS
ABOUT DEEPIKA VOONA
A Quality focused Molecular Biologist and a Project Management Co-Ordinator with a…
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