Team Member - Analytical Quality Assurance

Dr Reddys

1 - 3 years

5 - 10 Lacs

hyderabad

Posted:3 days ago| Platform:

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Skills Required

injectables method validation chemistry osd pharmaceutical quality control analytical quality assurance preventive action cgmp deviation aqa assurance lims test data qc packing material operations quality assurance review formulation pharmacy manufacturing api calibration

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Summary

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.

Qualification

Educational qualification:

Additional Information

About the DepartmentGlobal Manufacturing Organisation (GMO)

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