Executive Assistant

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.