Executive Assistant, Raniganj

Review and Documentation: Review specifications, Standard Test Procedures (STPs), Generic Test Procedures (GTPs), and analytical test data sheets. Review analytical reports for raw materials, packing materials, water samples, product samples, Out of Trend (OOT) results, and water trends ensuring compliance with quality standards.Handle and review technology transfer documents. Quality Control Monitoring: Monitor daily calibration activities, Preventive Maintenance Plans (PMP), instrument backup data, Excel worksheets lock, and user logbooks in the QC laboratory. Verify audit trails for QC lab instruments. Stability Studies:Review stability study protocols, analytical data, and summary reports related to product stability. Compliance and Investigations: Manage and review Change Controls, Out of Specification (OOS), Out of Trend (OOT) results, incidents, and investigations. Ensure compliance with Good Laboratory Practices (GLP) in the lab.LIMS Management: Review and approve Laboratory Information Management System (LIMS) related activities. Approve and issue configured Certificates of Analysis (COA) in LIMS. Training and Development: Attend and participate in relevant training programs to stay updated on quality and regulatory standards.