SAP Analyst
Role : Analyst, DSCSA Compliance / Serialization
DOMAIN : Pharma experience - MUST!!
Location : remote
Duration : 12mo
Rate : your best rate
Visa : All visas accepted (USC, GC preferred)
YES / NO
Years
SKILLS REQUIRED
Pharma Industry Experience
Serialization / Pharma
DSCSA regulations
Compliance with DSCSA regulations for serialization & traceability for pharmaceutical products
Serialization Software
- SAP ATTP
- TraceLink
- rfXcel
- LSPedia
Serialization onboarding
Maintain serialization data , product identifiers, transaction history & info to facilitate tracking & tracing
Master Data Governance
Cross-Functional Team Alignment
Supply Chain Process -Pharma
Roadmap Design
Process Integration 3PL, Warehouse, CMO
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 system s 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 3 rd Party Change Management
- SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP)
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