Role & responsibilities :

- Coordinate with manufacturing sites for execution of trial, scale-up, optimization, and process validation batches, including associated documentations.
- Review Batch Manufacturing Records (BMRs) to ensure accurate and compliant execution of batches.
- Review and compile Exhibit Batch Summary Reports (EB Batches) for regulatory and internal documentation.
- Track and ensure timely completion of protocols for execution of transfer batches.
- Verify development data, Master Formula Records (MFRs), and specifications for recent product development.
- Conduct specification reviews and compatibility studies for API source changes and new product introductions.
- Perform feasibility trials for site transfers and API source change activities.
- Review Process Validation Protocols and monitor critical manufacturing steps during validation activities.
- Ensure closure of all phases of protocol post execution of transferred batches.
- Prepare Risk Assessments for concerned sites involved in technology and site transfer activities.
- Collaborate with cross-functional teams (R&D;, QA, RA, SCM, Manufacturing) to ensure timely and successful completion of site and technology transfers.

📌 Senior Research Scientist (Hosur)
🏢 Viatris
📍 Hosur