Production - Secondary Packing & Track & Trace In charge

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.