Executive Assistant

3 - 5 years

3 - 12 Lacs

Posted:17 hours ago| Platform: Foundit logo

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Work Mode

On-site

Job Type

Full Time

Job Description

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.

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