Manager, Technical Transfer

Description
Job Responsibility
- To monitor scale up batches, exhibit batches, pre-validation batches & validation batches as per approved plan, and check/review/approve related documents.
- To co-ordinate for procurement of tooling, RM code creation, RM indent for site transfer projects & new products.
- To execute exhibit batches with alternate API source.
- To execute & monitor activity related to product site transfer projects & relevant documentation.
- To monitor critical process parameters of process validation batches of new/existing products & related documentation, ensuring successful launch of new products.
- To review batch manufacturing records (proposed & commercial), process study protocols & reports, trial batch protocols & reports.
- To review stability protocols, validation protocol, change controls, deviation, CAPA, investigations & other relevant documents.
- To support documentation, process validation, troubleshooting, process improvemen...