Be part of a collaborative research team implementing research and development trials. Conduct and coordinate quality efficacy trials, contributing to the development of new and existing formulations. Analyze, test, and approve the incoming raw materials as per the USP standards. Perform testing of products at various stages using sophisticated machines like HPLC, GC and IR. Perform the testing on the stability products, store the data using various data tools and submit the annual product reports (APRs). Responsible for the review and approval of the clinical and drug facts of new formulated products. Assist with design projects involved in development projects for new product formulation, new product procurement and product improvement. Participate as a member in research and development (RandD) projects, assisting with development and execution of design protocols, method development and validation. Gather pre-development information, actively searching for best-in-class technologies. Support RandD projects by participating in meetings and sharing technical information. Summarize trial lab data using various analytical tools like LIMS, SAS and ERP and present them to the management in the form of reports. Assist in evaluation of new products and/or raw materials. Work in a GMP and FDA regulated environment, responsible for FDA submissions. Develop, qualify, and validate analytical test methods for drug products and excipients purity using a variety of technologies including HPLC, GC, FT IR, Karl Fischer, UV-Vis, and other wet laboratory procedures. Perform assay, content uniformity, physicals for the manufactured products and determine they are safe to use. Write and approval of manufacturing batch record, SOP, STP for the OTC formulations (Semi-solids, Liquids). Responsible for writing customer complaints, investigations deviations, CAPA. Trim down the massive serialization data into tables by using VisioTT Plant Manager Software and SAS software in order to send it to customers.
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