Talentgigs
Website:
talentgigs.in
Job details:
Job Description
Title: Pharma Serialization Expert
Total Experience: 5–10+ years
Location: Hybrid Hyderabad /Remote
Employment Type: Full‑time
Job Description:
Position Overview
We are seeking a Pharmaceutical Serialization Expert to lead and support serialization and track-and-trace initiatives across global pharmaceutical supply chains. The role will focus on ensuring compliance with global regulations such as DSCSA (U.S.), EU FMD, and other global serialization mandates, while supporting system implementation, data integration, and operational readiness across manufacturing and distribution partners.
The ideal candidate will possess deep expertise in serialization architecture, regulatory compliance, supply chain integration, and pharmaceutical manufacturing systems.
---
Key Responsibilities
Serialization Program Leadership
· Lead serialization and track-and-trace initiatives across manufacturing, packaging, and distribution networks.
· Support global compliance with regulations such as DSCSA, EU FMD, ANVISA, SFDA, and other regional mandates.
· Collaborate with regulatory, quality, supply chain, and IT teams to ensure compliance readiness.
System Implementation & Integration
· Implement and manage serialization platforms such as:
o SAP ATTP
o TraceLink
o SAP ICH
o Arvato
o Systech
· Support integration with enterprise systems including:
o ERP systems (SAP)
o Manufacturing Execution Systems (MES)
o Warehouse Management Systems (WMS)
o Packaging line controllers
Data & Reporting
· Ensure accurate product serialization data exchange across partners.
· Manage master data for serialized products including GTIN, batch data, and serial numbers.
· Monitor reporting and compliance data submissions to government repositories.
Packaging & Manufacturing Support
· Support serialization implementation at packaging lines.
· Work with equipment vendors for:
o Line integration
o Vision systems
o Labeling and aggregation
· Ensure correct aggregation (unit, case, pallet) processes.
Compliance & Validation
· Ensure systems meet GxP validation requirements.
· Support:
o Computer System Validation (CSV)
o IQ/OQ/PQ documentation
o Audit readiness
· Maintain serialization documentation and SOPs.
Partner & Supply Chain Collaboration
· Coordinate with CMOs, wholesalers, and distributors.
· Ensure smooth data exchange and EPCIS compliance across trading partners.
· Support onboarding of new supply chain partners.
---
Required Qualifications
Education
· Bachelor’s or Master’s degree in:
o Supply Chain
o Pharmaceutical Sciences
o Computer Science
o Engineering
o Life Sciences
Experience
· 5–10+ years in pharmaceutical serialization or track-and-trace programs.
· Experience implementing serialization solutions in pharma manufacturing environments.
· Strong knowledge of global serialization regulations.
Click on Apply to know more.