Pharmaceutical Serialization Specialist
BirajTech Services
Seeking an experienced Pharmaceutical Serialization Specialist with strong knowledge of serialization, aggregation, track & trace systems, and global pharmaceutical regulatory compliance. Candidate will support implementation, integration, validation, and maintenance of serialization solutions.
Roles & Responsibilities
- Implement, configure, and support pharmaceutical serialization and aggregation solutions.
- Manage serialization processes across L1–L5 systems.
- Ensure compliance with global regulations, including US DSCSA, EU FMD, and applicable GS1 standards.
- Integrate serialization solutions with ERP, MES, packaging lines, and external systems.
- Handle EPCIS data exchange, serial number management, and product traceability.
- Troubleshoot serialization, aggregation, data exchange, and system integration issues.
- Coordinate with technical teams, vendors, and clients for implementation and support.
- Prepare technical documentation, validation reports, and SOPs.
- Support system testing, UAT, deployment, and production activities.
- Monitor serialization system performance and resolve operational issues.
- Minimum 3 years of experience in pharmaceutical serialization or track & trace.
- Strong understanding of serialization architecture (L1–L5).
- Knowledge of GS1 standards, GTIN, SGTIN, SSCC, and EPCIS.
- Experience with serialization platforms such as TraceLink, SAP ATTP, Systech, Antares Vision, or similar.
- Understanding of aggregation, commissioning, decommissioning, and reconciliation.
- Familiarity with REST APIs, XML, JSON, and system integration.
- Knowledge of pharmaceutical regulatory compliance and validation processes.
- Strong analytical, communication, and problem-solving skills.
- Experience with international pharmaceutical serialization projects.
- Knowledge of ERP/MES integrations.
- Understanding of GxP, GAMP 5, and CSV/CSA validation practices.
- Experience with cloud-based track & trace solutions.
- Client-facing implementation and technical support experience.