Serialization Implementation Specialist

1 day ago

Chennai, Tamil Nadu, India beBeeSerialization Full time ₹ 9,00,000 - ₹ 12,00,000
Serialization Specialist Role

We are seeking a skilled Serialization Specialist to join our team. In this role, you will be responsible for implementing and managing serialization systems across pharmaceutical packaging lines.

  • 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.

This is a critical position that requires strong analytical and problem-solving skills, excellent communication and documentation abilities, and the ability to work independently and in cross-functional teams.

Key Responsibilities:
  • Serialization System Management:
  • Implement and manage serialization systems to ensure compliance with global regulatory standards.
  • Configure and maintain serialization platforms, including Systech Guardian and Antares Vision.
  • Compliance & Regulatory:
  • Ensure serialization processes comply with GS1 standards, GxP, FDA, and EU FMD regulations.
  • 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).
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
Qualifications:
  • Bachelor's degree in Engineering, Life Sciences, or related field.
  • 7+ years of experience in pharmaceutical serialization or packaging automation.
  • Familiarity with GMP environments and validation processes.

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