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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
To review the Raw material, packing material and finished product specification and to update department Head whenever required
To carryout 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 softwares 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 ensure the review of calculation of the respective test protocol and daily release status
To ensure the testing of Raw material and packing material and analysis of in-process and finished product sample and it’s release according to standard operating procedure and specification
To ensure recording and documentation of all the data related to the testing on-line on daily basis and ensure the tractability of the same
To ensure preparation of the reagent and volumetric solutions
To support team members in preparation of SOPs
To review calibration reports
To escalate any abnormal results to department Head
To sign all the necessary test records and review the results of all the testing
To review real time analysis data as and when required
To review audit trails of analytical instruments as per defined procedure
To initiate and attend the quality related meetings and work towards quality culture