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
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