Sr Assoc II, Lab QA

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

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.

Equal Employment Opportunity

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