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Team Member - AQA

ConfidentialHyderabad / Secunderabad, Telangana

30+ days ago

Job description

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.

Qualifications

Educational qualification : A Bachelor's / Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field

Minimum work experience : 3 to 7 years of experience in pharmaceutical manufacturing or a similar role

Skills Required

empower , Method Validation, analytical review , Lims

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Team Member • Hyderabad / Secunderabad, Telangana