Team Member - AQA

• Review and approval of all analytical test data of Quality control.
• Review and usage decision of analytical reports in LIMS, Empower and SAP.
• Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments.
• Review the Analytical test report in LIMS.
• Review the reported results against specification and trends.
• Review the method validation and method transfer documents.
• Review the instrument calibrations and working standard qualification records.
• Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure.
• Monitoring of analytical activities in Quality control laboratory.
• Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval.
• Verification and review of the audit trails for Standalone, Empower and LIMS.
• Ensure cGMP / cGLP compliance.
• To follow Safety, Health and Environmental procedures and practices.
• Review and approval of excel sheet validations.
• Review results acceptance for API and Excipients and Packing material.
• Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols.
• Handling of Robotic Process Automation of Chromatography Data review (RPACD)
• To carry any other activities assigned by upward reporting staff.

Qualifications

Educational qualification:

Minimum work experience