Track & Trace SME (Deputy Manager)

Job SummaryThe SME for Track & Trace Serialization will be responsible for supporting and managing enterprise serialization and traceability systems across manufacturing, packaging, warehousing, and supply chain operations. The role will oversee day-to-day operations, incident management, implementation of serialization projects, regulatory compliance activities, and integrations between Level-4/Level-3/Level-2 systems including TraceLink, Optel OSM, SAP, and Packaging Line Controllers.The incumbent will collaborate with business stakeholders, quality assurance, regulatory affairs, supply chain, manufacturing, and external partners to ensure uninterrupted serialization operations and regulatory compliance across global markets.Key ResponsibilitiesSerialization Operations SupportProvide L2/L3/L4 application support for Serialization and Track & Trace platforms.Monitor daily serialization activities and ensure smooth production execution.Manage product onboarding, commissioning, aggregation, shipping, and reporting activities.Support issue investigation, troubleshooting, and root cause analysis of serialization incidents.Coordinate with vendors and service providers for issue resolution.System Administration & ComplianceManage user access, role assignments, and periodic access reviews.Ensure compliance with GxP, 21 CFR Part 11, Annex 11, GAMP5, and Data Integrity requirements.Support audit readiness and inspections related to serialization systems.Maintain system documentation including SOPs, Work Instructions, Risk Assessments, Validation Documents, and Change Controls.Participate in periodic reviews and compliance assessments.Project ImplementationLead deployment of serialization solutions for new customers and markets.Support system upgrades, enhancements, and integrations.Coordinate validation and qualification activities for serialization applications.Integration ManagementSupport integrations between:TraceLink Level-4 PlatformOptel OSM Level-3 PlatformSAPWMSPackaging Line SystemsSiteMaster/MES SystemsAnalyse interface failures and ensure timely resolution.Monitor data exchanges and transaction processing.Partner & Regulatory ConnectivitySupport onboarding and connectivity with CMOs, Customers, Distributors, and Regulatory Agencies.Manage EPCIS data exchange and regulatory reporting.Support DSCSA, EU FMD, UAE Tatmeen, Australia, and other country-specific serialization regulations.Continuous Improvement & COE DevelopmentContribute to the establishment of Serialization Center of Excellence (COE).Develop best practices, governance models, and standard operating procedures.Conduct user training and knowledge-sharing sessions.Drive process optimization and automation initiatives.Required Technical SkillsSerialization PlatformsTraceLinkOptel Open SiteMaster (OSM)Optel TracksafeEnterprise SystemsS4 HANAWMS IntegrationMES IntegrationCompliance & ValidationComputer System Validation (CSV)GAMP521 CFR Part 11EU Annex 11Data Integrity RequirementsChange Control ManagementRisk Assessments (FMEA/FMECA)Technical KnowledgeXMLEPCISWeb Services/API IntegrationsSQL QueriesInterface MonitoringIncident ManagementServersEducational QualificationBachelor's Degree in Engineering, Pharmacy, Computer Science, Information Technology, or related discipline.Experience7 to 10 years of overall experience.Minimum 5 years of hands-on experience in Pharmaceutical Serialization and Track & Trace systems.Experience supporting global serialization operations across multiple markets.Experience in regulated pharmaceutical manufacturing environments.Preferred CompetenciesFunctional CompetenciesSerialization and Aggregation ProcessesSupply Chain TraceabilityPharmaceutical Manufacturing OperationsRegulatory ComplianceVendor ManagementProject ManagementBehavioural CompetenciesStrong Analytical SkillsProblem SolvingStakeholder ManagementCommunication SkillsLeadership PotentialCustomer FocusAbility to work under pressure during production-critical incidentsPreferred Industry ExperiencePharmaceutical ManufacturingLife SciencesContract Manufacturing Organizations (CMO)Pharmaceutical Supply Chain & DistributionGlobal Serialization Programs