Job Title

About the CompanyGranules India Limited is one of the vertically integrated, high-growth pharmaceutical manufacturing company in India. Based out of Hyderabad, India, it is into manufacturing Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediaries (PFIs) and Finished Dosages (FDs).About the RoleLead global Track & Trace (Serialization) and EDI solutions using Tracelink across US, EU, India, and other regulated markets. Ensure end-to-end data flow from packaging lines to supply chain partners and health authorities, maintaining serialization compliance and B2B integrations with SAP ERP, MES (PAS-X), and WMS systems.Responsibilities- ERP/MES/WMS Integration: Establish end-to-end data flow from Pack Level to Health Authorities via SAP ECC/S4HANA, PAS-X MES, WMS, and L4/L5 systems. Ensure real-time serialization synchronization, bi-directional data accuracy, and seamless interface performance across enterprise systems. - Regulatory Compliance & Reporting: Ensure timely regulatory submissions to EU Hub, US DSCSA networks, and national repositories. Monitor evolving regulations, manage alert resolution, and partner communication. Support regulatory inspections and audit readiness. - Validation & Change Control: Drive CSV activities per GxP and 21 CFR Part 11 - author URS, FRS, IQ/OQ/PQ documentation. Execute change control, impact assessments, UAT coordination, and maintain validation lifecycle. Ensure audit-ready documentation. - ITIL Governance & Issue Management: Establish incident, problem, and release management frameworks under ITIL. Manage SLA adherence, root cause analysis, and minimize system downtime. Log support tickets and coordinate resolution across global teams. - Data Governance & Master Data: Maintain master data accuracy for GTINs, serial ranges, partner IDs across SAP, Tracelink, EDI systems. Implement data validation rules, quality monitoring, and standardization initiatives ensuring data integrity across serialization hierarchies (unit, case, pallet). - Vendor & Partner Management: Coordinate with Tracelink and EDI vendors for support, SLA compliance, and cost optimization. Lead license renewals and contract negotiations. Manage CMO, 3PL, distributor onboarding including connectivity testing and certification. - SME Leadership & Audit Support: Act as SME for serialization, aggregation, and EDI. Support regulatory inspections with documentation and compliance evidence. Provide leadership to IT teams and guide cross-functional stakeholders on Track & Trace and EDI standards.Qualifications- Bachelor's/Master's in Computer Science, Engineering, or related field - 8-12 years pharmaceutical IT/packaging/supply chain experience with 3-5 years Tracelink expertise and 3+ years EDI systems - Proven expertise in US DSCSA, EU FMD, India DAVA, Brazil, Russia serialization regulations - Experience integrating Tracelink with SAP ECC/S4HANA, PAS-X MES, WMS, and L4/L5 systems - Hands-on EDI mapping, AS2/SFTP/VAN protocols, middleware platforms (Seeburger, SAP PI/PO, Mulesoft) - GxP, CSV lifecycle, ITIL processes, and cross-site global implementation experience - Strong analytical, problem-solving, and stakeholder management skills across international teamsRequired Skills- Tracelink Suite mastery, EDI standards (EDIFACT, X12, XML), GS1 serialization (GTIN, SGTIN, SSCC) - System integration architecture, interface troubleshooting, data governance, and master data management - Global program management, validation protocols, regulatory reporting, and audit readiness - Cross-cultural communication, vendor management, and translation of compliance needs to technical solutionsPreferred Skills- 100% on-time compliance across all markets with zero regulatory non-compliance findings - Successful partner onboarding within SLA, >99.5% data accuracy, timely regulatory submissions - Reduced system downtime, successful validation cycles, and improved end-to-end traceability - Cost optimization through vendor management and strong stakeholder satisfaction