- Execution of Process feasibility batches.
- To observe and analyze the key parameters in trial batches & stability batches.
- To write and maintain the Laboratory notebook.
- To execute scale up batches.
- Review of API,RM,PM COA and specifications
- Q3 Characterization and report preparation
- Support for Life cycle management, AVD, Customer & Site transfer projects.
- Compilation of Stage gate, PDR & Deficiency response
- To compile and review BOM, MFC, BPR and BMR of AVD, Customer & Site transfer projects
- Execution of scale up and exhibit batches
- To compile Process optimization reports
- Collaborate with CFT (F&D;, ADL, Sourcing, Project team etc.) for smooth execution of various projects
- Interaction with QA, QC, production and Technology Transfer at manufacturing location for scaling up, technology transfer and continuous improvement initiative of projects