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Hetero Labs Limited

Executive Assistant

3-5 Years
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  • Posted 18 days ago
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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.

More Info

Job Type:
Function:
Employment Type:
Open to candidates from:
Indian

About Company

We are one of the world’s leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with a presence in 140+ countries and backed by 30 years of experience in the pharma sector. We endeavour to serve patients by moulding science and technology into therapies to improve health outcomes and people’s lives.

Job ID: 122723507

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