What You Will Achieve
In this role, you will:
Evaluate and review commercial drug batches to ensure compliance with established specifications.
Ensuring Zero Defect Technology transfer for new product transfers into site.
Quality Support and review of Scale-up, pilot bio batches and exhibit beaches to meet regulatory expectations.
Reviews of Process validation protocols and reports to meet regulatory expectations.
Review of Optimization Report /Technology Transfer Report, Analytical Data Sheet and Stability Data.
Responsible to manage New Product Introduction (NPI) projects.
Review and approval of Project validation protocols, QRM’s, Cleaning validation protocols and reports, process validation protocols & reports, Filter validation protocols & reports.
Review of Analytical Method Transfer and method validation Reports and ensuring the key changes mentioned...