Job Description

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you will find purpose and pride. 

Essential Duties and Responsibilities:

This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.

  • To complete the planned work (Method validation/Submission Studies/Regulatory query) in stipulated time frame given by sub-department manager.
  • To perform all the testing and data recording of API samples, Development Product samples, Validation Samples, Stability samples, Bulk hold samples, RLD samples, PDR samples etc. according to draft/approved Method of analysis or current Pharmacopoeia.
  • To operate the different instruments like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter etc. as per approved standard operating procedures.
  • To calibrate the Instruments as and when required (Daily/as per schedule) like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter etc. as per approved standard operating procedures.
  • To use live reference standards, working standards and Impurity Standards for analysis and maintain their records.
  • To verify the shelf life of chemicals and reagents before performing analysis of material or product.
  • To follow good documentation and ALCOA++ practices.
  • To follow the good Laboratory practices in the Department.
  • To follow the instruction and procedure as mentioned in the approved protocol.
  • To keep track of routine requirements. Inform and ensure timely procurements of the same to respective person or Department.
  • To Report and investigate any failure / abnormal observation / deviation / Non-Compliance to sub-department manager and seeking for the solutions.
  • To communicate project related issues to sub-department manager and follow the action plans.
  • To check the trend of results before reporting the results.
  • To keep the status of daily work and report to sub-department manager on daily basis.
  • To prepare standard operating procedures (SOPs) and standard formats for Documentation.
  • To verify the instruments after maintenance of the Instruments.
  • To check preventive maintenance, Breakdown Maintenance and perform risk assessment. To report preventive maintenance and Breakdown Maintenance to sub-department manager.
  • To represent subject matter expertise in the areas of analysis internally and externally as needed.
  • To make Analytical problem-solving efforts to meet urgent business needs.
  • To focus on innovation, process improvement, and/or operational excellence.
  • To execute and manage projects/programs utilize established methods, techniques, or approaches.
  • To Implement new or improved techniques and procedures around specific tasks; write and implement SOP's.
  • To complete the training as per the quality matrix targets.
  • To Maintain knowledge of relevant regulatory requirements related to R&D to ensure compliance in all research, data collection and reporting activities.
  • In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance.

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