Production - Secondary Packing & Track & Trace In charge

Biological E; New Delhi; On-site; INR 1,200,000 - 2,500,000; Full time

Job summary

Biological E is seeking an experienced professional to manage secondary packaging, serialization, and track-and-trace operations in Delhi. The role involves optimizing injectable packaging lines for vials, PFS, and device packing, and leading cross-functional serialization initiatives with IT, production, and QA teams.

You will oversee IQ/OQ/PQ qualification, ensure regulatory compliance with USFDA, MHRA, and WHO-GMP, and maintain GMP documentation, including VMPs and SOPs, under tight timelines.

Qualifications

• Knowledge of regulatory requirements (USFDA, MHRA, WHO-GMP).
• Hands-on experience with serialization software/hardware platforms (ACG Vision, Antares Vision, Tracelink).
• Deep understanding of GS1 and DataMatrix barcode standards.
• Knowledge of line automation and PLC-based packaging networks.

Responsibilities

• Lead the qualification (IQ/OQ/PQ) of serialization and packaging equipment.
• Manage Track & Trace operations to ensure regulatory compliance and data integrity.
• Prepare, review and maintain GMP documentation including Validation Master Plans (VMP), SOPs, risk assessments and deviation reports.

Skills

Regulatory knowledge

Serialization software

Barcode standards

Line automation

Tools

ACG Vision

Antares Vision

Tracelink

Job description

Secondary Packaging Equipment & production activity Handling

• Equipment Operations: Handle and optimize injectable secondary packaging lines, specifically for Vials, Prefilled Syringes (PFS), and Device Packing.
• Process Efficiency: Troubleshooting and improving packaging line automation and vision inspection systems.

Track & Trace and Serialization

• Regulatory Compliance: Manage end-to-end Track & Trace operations to comply with USFDA (DSCSA) and EU (FMD) regulations.
• System Integration: Lead serialization integration workflows for customers, clients, and supply chain partners.
• Data Management: Oversee Level 1 to Level 4 (L1-L4) serialization software architecture and data exchange.

Qualification & Documentation

• Validation: Lead the qualification (IQ/OQ/PQ) of serialization and packaging equipment.
• Documentation: Prepare, review, and maintain GMP documentation including Validation Master Plans (VMP), Standard Operating Procedures (SOPs), Risk Assessments, and deviation reports.

Required Technical Skills

• In-depth knowledge of regulatory requirements (e.g., USFDA, MHRA, WHO-GMP).
• Hands-on experience with top-tier serialization software and hardware platforms (e.g., ACG Vision, Antares Vision, Tracelink )
• Deep understanding of global aggregation requirements and barcode standards (GS1, DataMatrix).
• Technical knowledge of line automation and PLC-based packaging networks.

Preferred Behavioural Attributes

• Leadership skills to manage Team & cross-functional teams (IT, Production, Quality Assurance).
• Excellent communication skills for client-facing serialization integration projects.
• Sharp analytical and troubleshooting abilities under tight regulatory timelines.