- Coordinate with site for execution of trial, scale up, optimization, exhibit and process validation batches and relevant documentation
- Review of BMR (Batch manufacturing records) for execution of batches
- Review of exhibit batch summary reports EB Batches
- Tracking and ensuring completion of Protocol for execution of transfer batch
- Verify development data master formula record and specification for current product development
- Perform specification review and compatibility studies for API source change and new product development activities
- Perform feasibility trials for site transfers and API source change activities
- Review of process validation protocol and monitoring critical manufacturing steps for process validation activities
- Closure of all phases of protocol for execution of transferred batches
- Preparation of risk assessment for concerned site for technology and site transfer activities
- Coordination with cross functional team for timely completion of site and technology transfers

📌 Team Lead (Bengaluru)
🏢 Viatris
📍 Bengaluru