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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Skills Required
Qa, Exception Handling, Logistics, VRS, IT, traceability