| SAP ATTP DSCSA / Serialization-Analyst||Remote|| at Remote, Remote, USA |
| Email: [email protected] |
| Job Description : Resolve serialization-related issues, discrepancies, errors, system malfunctions on inbound & outbound of pharmaceutical product s Perform serialization activities for product received with no data or partial data 3rd party support teams to implement serialization systems and processes in accordance with regulatory requirements Assist with serialization onboarding activities wit h upstream/ downstream supply chain partners to establish system and/or portal connectivity (customers) Maintain serialization data , including product identifiers, transaction history, transaction info to facilitate product tracking and tracing Assist in training and support on serialization best practices and compliance requirements Stay current with changes in DSCSA regulations and industry best practices Follow compliance with DSCSA regulations related to serialization and traceability for pharmaceutical products Generate reports on serialization activities and compliance status for internal and external stakeholders Experience in software systems (experience with serialization software ie. , SAP ATTP, TraceLink, rfXcel, LSPedia ) Required: Knowledge of DSCSA regulations and serialization requirements Knowledge of pharmaceutical industry practices, supply chain processes Geographic Regulatory Assessment Serialization Pilot and Roadmap Design Technology Landscape Assessment DSCSA Compliance Cross-Functional Team Alignment Process Integration with 3PL, Warehouse, and CMO Track and Trace Vendor Selection Serialization Vendor Assessment Operationalization of Serialization Strategy and Processes Master Data Governance Validation Process Implementation Vendor and 3rd Party Change Management SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP) -- Keywords: information technology SAP ATTP DSCSA / Serialization-Analyst||Remote|| [email protected] |
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| Fri Sep 13 20:22:00 UTC 2024 |