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.

Required Skills & Qualifications





- 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.
- Robust analytical, communication, and problem-solving skills.

Preferred 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Pharmaceutical Serialization Specialist (Ahmedabad)
🏢 BirajTech Services
📍 Ahmedabad