Associate - Supply Chain Traceability Ajanta Pharma Ltd
Ajanta Pharma Ltd
Office Location
Full Time
Experience: 3 - 3 years required
Pay:
Salary Information not included
Type: Full Time
Location: All India
Skills: Exception Handling, Data exchange, compliance monitoring, System Testing, Documentation, Implementation, VRS, Regulatory Compliance, Product Serialization, traceability, T3 Data Submission, Middleware System, FDA Regulations, EPCIS, Audits, Inspections
About Ajanta Pharma Ltd
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.,