Functions:

• Scrutinize the test/analysis reports of drug samples.
• Scrutinize the investigation reports of the Drug Inspectors.
• To scrutinize the reports of third party regarding inspection of Pharmaceutical Manufacturing firm, POS and Distribution setup.
• Prepare show cause & personal hearing notices to the accused persons.
• Issue directions, permission to register FIR and permission for prosecution to drug inspectors.
• Prepare brief of cases to be placed at agenda for the PDCU meeting.
• Manage, plan and direct the quality control of drug testing laboratories to ensure that laboratories provide the highest quality analytical support for manufacturing while ensuring compliance with protocols and safety regulations.
• Ensure that testing is executed in a timely and compliant manner.
• Execute and approve laboratory investigations.
• Review and investigate laboratory data.
• Review and approve protocols and reports such as method validation, method transfer, process validation and stability.
• Provide leadership, management, evaluation and training to all laboratory employees.
• Establish and implement Key Performance Indicators (KPIs) structure.