
Being a core member of Serialization - Center of Excellence Team at CTS(Cognizant), handling end to end implementations and consulting activities.
Keen Domain knowledge on Pharma & Health care industries and their regulatory compliance .
Having 12 years of total experience in Pharmaceutical & Health care IT & SCM activities.
• Well understanding on EUROPEAN UNION FMD & UNITED STATES DSCSA Serialization Regulations for implementation.
• Well experienced on usage of TraceLink Application Modules for handling different Business Scenarios, Use cases and preparation of Analysis Data Reports for EU Alerts, VRS history and Info Exchange Extracts.
• Thoroughly handled Partners (CMO’S & CUSTOMERS) Onboarding with TraceLink Application as per Business requirement and involved in CSV validations for qualification of partner Onboarding.
• Well Supportive to Serialization functional users, Preparation of Serialization SOP’s and troubleshoot the issues with corrective and preventive actions.
Serialization Implementation
CSV Documentation
EXCEL, POWER BI
Cloud, Devops
TRACK AND TRACE
OQ & PQ Testing
Scripting ( Python, Linux)
Applied Data Science Certified