Rupam Debnath
Life Sciences II Business Analyst II GxP Specialist ll QMS ll CTMS ll TMF ll Document Management ll Scrum Master ll Computer System Validation (CSV) ll Immediate joiner II
- Role
- Application Manager at Cognizant
- Location
- Kolkata, WB, IN
- LinkedIn followers
- 500 followers
About Rupam Debnath
At Cognizant, my focus has revolved around ensuring impeccable compliance and document…
Experience
Application Manager
May 2021 — Present · Kolkata, IN
Responsible for creating, review and maintain periodic application review documents, period accounts review documents, period control assessments documents, SOP/WI/WP documents, change impact assessment documents, deviation investigation documents, URS documents, data extraction/archival/migration plan/reports documents, application retirements plan/reports documents as per business standards.• To oversee and manage documentum (GxP) applications, day-to-day operation activities, to coordinate with different teams/departments to ensure business requirements/activities are followed up and closed within deadline.• Sound knowledge of 21CFR part 11, CSV, ITIL, deviation/CAPA management, release management.
Education
Garden City University
Bachelor's degree, Biochemistry
2007 — 2010
Assam (Central) University
Doctor of Philosophy - PhD, Biotechnology
Vellore Institute of Technology
Master of Science - MS, Biotechnology
2010 — 2012
Assam (Central) University
Doctor of Philosophy - PhD, Clinical and Industrial Drug Development
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