Role Objective:
The design, development, and regulatory compliance of robust primary, secondary, and tertiary packaging solutions for Solid Orals, Ophthalmics, Injectables, and Drug-Device Combination Products across USV sites and CDMOs. This role ensures seamless launch execution, cost optimization, vendor qualification, and full compliance with global regulatory standards (ISO/USP)
KEY RESPONSIBILITIES
- Design & Innovation: Design and develop primary, secondary, and tertiary packaging solutions for Solid Orals, Ophthalmics, Injectables, and Drug-Device Combination Products (including Pen Injectors and Autoinjectors). Introduce new packaging concepts, technologies, and continuous improvements for current or existing product categories.
- Regulatory Compliance & Technical Documentation: Prepare and review technical documentation for regulated markets, including Threshold Analysis Reports, Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), and Medical Device Reporting (MDR) for 510(k) submissions. Ensure compliance with ISO 11608, ISO 11040,



ISO 13485, ISO 14971, USP , USP , USP , USP , and USP . Prepare technical responses for regulatory queries and briefing packages.
- Process Optimization & Commercial Execution: Prepare and review Specifications, STPs, MPCs, BOMs, and BPRs for submission and commercial launch batches at USV sites and CDMO/CMO facilities. Oversee packaging activities for submission/launch batches, evaluate packaging line machinery compatibility, lead blister change-part development, conduct equipment trials (FAT/SAT), and optimize line processes.
- Value Engineering & Risk Management: Identify, evaluate, and implement continuous cost-optimization and value-engineering projects across packaging formats. Lead Risk Management activities, Failure Mode and Effects Analysis (FMEA), and Human Factors Equivalency studies.
- Testing & Characterization: Execute functionality and physical performance testing for solid oral pac

📌 Deputy Manager- Packaging Development (Govandi East)
🏢 USV
📍 Govandi East