Associate - Supply Chain Traceability

Ajanta Pharma Ltd

0 years

0 Lacs

Mumbai Metropolitan Region

Posted:4 days ago| Platform:

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Skills Required

traceability support serialization logistics data compliance middleware regulations testing documentation verification audits

Work Mode

On-site

Job Type

Full Time

Job Description

Job Description:

Support daily DSCSA operations including product serialization, traceability, and exception handling.
Coordinate with internal teams (QA, IT, Logistics) and external partners (CMOs, 3PLs, wholesalers) to ensure accurate product data exchange.
Monitor and investigate DSCSA compliance issues such as "data no product" and "product no data" exceptions.
Ensure accurate and timely submission of T3 data (Transaction Information, Transaction History, and Transaction Statement).
Reconcile all outbound shipments from the 3PL using the middleware system to ensure compliance with DSCSA guidelines.
Maintain records of DSCSA-related activities in compliance with FDA regulations.
Assist with system testing, documentation, and implementation of serialization and verification solutions (e.g., EPCIS, VRS).
Stay updated on evolving FDA DSCSA regulations and industry best practices.
Participate in audits, inspections, and readiness exercises.

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