Serialization

3 days ago


Chennai, Tamil Nadu, India LTIMindtree Full time
Hiring for Serialization Specialist – Pharmaceutical Industry-PAN India Location Job Title: Serialization Specialist – Pharmaceutical Industry

Experience Level: Mid to Senior (7–12 years preferred)

The Serialization Specialist is responsible for implementing, managing, and maintaining serialization systems across pharmaceutical packaging lines to ensure compliance with global regulatory standards such as DSCSA (US) and EU FMD. This role supports anti-counterfeiting efforts, enhances supply chain transparency, and ensures product traceability from manufacturing to distribution.

Serialization System Management

Manage databases and digital fingerprinting systems such as Guardian Digital Fingerprint , Guardian UniSecure , and Guardian UniTrace .

Oversee integration of serialization software with packaging equipment and ERP systems.

Compliance & Regulatory

Maintain audit readiness and support internal/external inspections.

Technical Support & Troubleshooting

Provide hands-on support for serialization and vision inspection systems.

Lead root cause analysis (RCA) and implement corrective/preventive actions (CAPA).

Collaborate with IT and engineering teams to resolve system issues and optimize performance.

Project Execution

Lead serialization-related projects including system upgrades, new line implementations, and artwork changes.

Coordinate with cross-functional teams including QA, packaging, supply chain, and regulatory affairs.

Training & Documentation

Develop and deliver training programs for operators and maintenance staff.

Maintain detailed records of system configurations, incidents, and resolutions.

Systech Guardian, Guardian Digital Fingerprint, Guardian UniSecure, Guardian UniTrace

BarTender, SAP ATTP, TraceLink, Codesoft

PLCs, industrial controllers, network infrastructure

Bachelor's degree in Engineering, Life Sciences, or related field.

~7+ years of experience in pharmaceutical serialization or packaging automation.

~ Hands-on experience with serialization systems and regulatory compliance.

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