Rohit Jaiswal

Hands-on experience with TraceLink platform for EU pharmaceutical serialization and track & trace compliance.

• Strong knowledge of EU FMD (Falsified Medicines Directive) requirements for product serialization and verification.

• Experience in managing serial number commissioning, aggregation, and reporting through TraceLink system.

• Integration and data exchange with EMVS (European Medicines Verification System) via TraceLink.

• Good understanding of GS1 standards (GTIN, SSCC, DataMatrix codes) used in EU serialization.

• Experience in Level 3 (Site Server) and Level 4 (Enterprise/Cloud – TraceLink) systems.

• Managing master data creation and product setup for serialization in TraceLink.

• Coordination with packaging lines (Track & Trace machines) for real-time data upload and verification.

• Knowledge of serial number provisioning, upload, commissioning, decommissioning, and rework processes.

• Handling exceptions, alerts, and troubleshooting in TraceLink environment.

• Ensuring compliance with EU regulations and audit readiness (GxP, 21 CFR Part 11 – where applicable).

• Experience working with contract manufacturing organizations (CMOs) and supply chain partners via TraceLink network.

• • Experience with TraceLink for EU pharmaceutical serialization and track & trace compliance (EU FMD).• Knowledge of GS1 standards, serial number management, and integration with EMVS system.• Skilled in data handling, commissioning, aggregation, and ensuring regulatory compliance.
• Supervised secondary packing and production areas as per cGMP & SOPs.
• Managed manpower, ensured hygiene, training, and efficient routing of materials.
• Handle with antra’s vision gts server

• Project plant installation qualification face and validation batch Pharma pack bottle line, BQS blisters packing machine and secondary packaging Labelling machine, jekson track & trace.
• Created maintenance reports and documented technical procedures.
• Supported system upgrades and provided staff training for better productivity.
• Naidupeta, Nellore

• Conducted preventive maintenance and routine inspections.
• Diagnosed and resolved equipment issues to reduce downtime.
• Sikkim

• Supported installation and setup of new equipment.
• Worked with engineers to improve machinery performance.
• Indore