Serialization

2 days ago

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

Job Title: Serialization Specialist – Pharmaceutical Industry

Location: PAN India Location

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

Job Summary:

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.

Key Responsibilities:

Serialization System Management

- Configure and maintain serialization systems including Systech Guardian, Antares Vision, SeaVision, Optel OSM, Rfxcel, and PCE PSM.
- 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

- Ensure serialization processes comply with GS1 standards, GxP, FDA, and EU FMD regulations.
- Maintain audit readiness and support internal/external inspections.
- Generate and maintain documentation including SOPs, validation protocols, and change controls.

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.

Required Skills & Technologies:

- Serialization Platforms:
- Systech Guardian, Guardian Digital Fingerprint, Guardian UniSecure, Guardian UniTrace
- Antares Vision, Antares Tracking System
- SeaVision, Optel OSM, Rfxcel, PCE PSM
- Compliance & Standards:
- GS1 Standards, GxP Compliance, DSCSA, EU FMD
- Technical Tools:
- BarTender, SAP ATTP, TraceLink, Codesoft
- PLCs, industrial controllers, network infrastructure
- Soft Skills:
- Strong analytical and problem-solving skills
- Excellent communication and documentation abilities
- Ability to work independently and in cross-functional teams

Qualifications:

- 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.
- Familiarity with GMP environments and validation processes.

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