Research Assoc I, R&D - ADL

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.  Summary : The person will be responsible for the execution, analysis and review of analytical work (method development, pre-validation, validation, technology transfer and analysis of stability sample) performed at Complex Product Development team, GPRD, following GxP practices. The Person is also responsible to provide analytical support to Baxter Global, and Baxter’s Contract manufacturing sites as required.   Essential Duties and Responsibilities :   ·     To plan and perform sample analysis (analytical method development, validation, technology transfer, etc) activity following GxP & GDP practices for regulatory submissions for complex injectables like peptides , iron formulations , etc. Assist in regulatory query responses for Complex Products. ·       To perform testing of Complex Injectable samples, including, API, development, validation, stability, bulk hold, RLD, PDR and any other samples as required, according to appropriate method of analysis. ·       To be competent in analytical problem-solving, focus on innovation, process improvement and operational excellence. Knowledge of published literature and databases is essential. ·       To keep track of all activities related to product analysis, ensure completion in the stipulated time, and inform the Sub-department manager if any deviation or issues observed. ·       Preparation and review of analytical reports, SOPs and MOAs by referring to GQP & current pharmacopoeia as per requirement. ·       To carry out all testing and data recording according to the approved SOPs following GDP & ALCOA+ principles and current pharmacopoeia. Ensure data recording in ELN with timely sign off and closure. ·       To use appropriate reference and working standards for analysis and maintain their records. To verify the shelf life of the chemical or reagent before performing analysis of the material or product. ·       To complete all training as per the quality matrix targets. To keep the status of daily work and report to Sub-department Manager on daily basis as per requirement. ·     To perform or review the calibration records of instruments as per approved SOPs. To check pre-requisites, assist in installation and qualification of laboratory instruments in timely manner as per organization requirement. ·       To manage preventive & breakdown maintenance, perform risk assessment and suggest immediate corrective actions as and when required. To report conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager. To Report and investigate any failure / abnormal observation / OOT / OOS / deviation / Non-Compliance to sub-department manager and seeking for the solutions. ·       To list all resources required for the study, keep track of routine requirements, ensure timely procurement of the same, and verify the materials received for analysis from suppliers.  ·       To review stability program for finished product, monthly data logger reports and qualification documents for stability chambers. ·       To ensure timely review of DMF of API vendors, manage API and Excipient Vendor Approval