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.
📌 Production Secondary Packing & Track & Trace In Charge Hyderabad
🏢 Biological E
📍 Hyderabad
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