Assoc II, Lab QA Job at Baxter (Ahmedabad)

Job Responsibility

To review of analytical documents generated during the analysis of QC, Stability and Microbiology for adequacy and accuracy
To carry out investigation in-case of out of specification (OOS) and deviation and take the corrective and preventive action (CAPA)
To ensure the calibration of all the analysis instruments is accurate
To sign off electronically the final document of sample set generated through Empower and all other software where (E-signature is applicable) for all the analysis in QC, stability & microbiology
To ensure the preparation of working standards as per the guidelines and pharmacopoeias
To review of calculation of the respective test protocol and daily release status
To ensure online recording and documentation of all the data related to the testing on daily basis and ensure the tractability of the same
To check the record of preparation of the reagent and volumetric solutions
To prepare SOP as per the change proposal
To review calibration reports and report any observations to the Manager if any
To review audit trails of analytical instruments as per defined procedure
In absence of Team, Manager will ensure these roles & Responsibilities
To bring to the notice about any abnormalities and non-conformity to Manager

To review of analytical documents generated during the analysis of QC, Stability and Microbiology for adequacy and accuracy
To carry out investigation in-case of out of specification (OOS) and deviation and take the corrective and preventive action (CAPA)
To ensure the calibration of all the analysis instruments is accurate
To sign off electronically the final document of sample set generated through Empower and all other software where (E-signature is applicable) for all the analysis in QC, stability & microbiology
To ensure the preparation of working standards as per the guidelines and pharmacopoeias
To review of calculation of the respective test protocol and daily release status
To ensure online recording and documentation of all the data related to the testing on daily basis and ensure the tractability of the same
To check the record of preparation of the reagent and volumetric solutions
To prepare SOP as per the change proposal
To review calibration reports and report any observations to the Manager if any
To review audit trails of analytical instruments as per defined procedure
In absence of Team, Manager will ensure these roles & Responsibilities
To bring to the notice about any abnormalities and non-conformity to Manager