Opportunity brief
Baxter International is hiring for the role of Research Associate!
Responsibilities of the Candidate:
- 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 process of New Product and existing products. - To review the status of daily work of the team and report to the Manager
Requirements:
- Good experience in the execution of analytical method development, validation and technology transfer and routine analysis for peptides and iron colloidal drug products for regulatory submission. - Competency with method relevant to iron DS/DP analysis, including particle size distribution by gel filtration chromatography, light scattering/diffraction/obscuration methods, assay of various iron forms, e.g. ferrous, ferric, labile iron, chelation assays, reduction potential and kinetics, etc, is strongly desired. - Basic Knowledge and execution of Chemical Analysis using techniques relevant to complex injectables - Knowledge of pharmacopoeia, ICH Guidelines. - Execution of Operational and Calibration of Instrument on periodic basis - Trouble shooting of various problems obtain during the during analysis. - Knowledge of Transfer of Technology. - Knowledge of Good Laboratory Practice and Good Documentation Practices