Associate Manager - Quality Assurance

Review , approval of change controls ensure the compliance of SOPs related to technology transfer .

Review and approval of validation protocols , PRQs and PR’s to ensure validation life cycle .

Support production related documents review and approvals.

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 valida...