Title:  Assistant Manager - API

Preparation and Review of Standard Operating Procedures.

Review of BMR, BPR, ECR, PFD etc.

Responsible for Change Control Management.

Preparation and Review of Annual Product Quality Review.

Responsible for label management.

Responsible for Process Performance Qualification and Cleaning Validation.

Handling of Deviation.

Responsible for OOS and OOT investigation related to manufacturing.

Responsible for Preparation and review of Risk Assessments.

Review and evaluation of Nitrosamine impurities of the API molecules.