Senior Executive

3 days ago

Vadodara Gujarat, India Sun Pharmaceutical Industries Full time

To design and conduct experiments for preformulation formulation optimization of Injectable and long acting complex non oral dosage form Implant In-situ-gel etc based on QbD approach To execute the experiments as per Design of experiments To do literature search patent search and prepare summary report for ANDA projects To prepare product development study protocols and reports as per regulatory requirements To enter the experimental details observations and test request in the eLNB METIS software Experimental trials and stability study results compilation and interpretation using MINITAB software To have sound knowledge in Lyophilization cycle development terminal sterilization To prepare Technology Transfer documents like MF Risk Assessment based upon CPP CQA To prepare justification for import material documents for form 29 application and Common Pharmaceutical Document for DCGI submission To execute scale up exhibit batches at plant and prepare scale up summary report To prepare Stability protocol as per regulatory requirement To prepare Product Development Report Risk assessment report for Elemental impurities Residual solvents and Extractable for regulatory submission To prepare pre-ANDA meeting package scientific justification and or report for various regulatory agency To prepare SOPs related to laboratory equipment instrument To be a part of Equipment Instrument Qualification activity in case of procurement of any new Equipment Instrument and prepare and review qualification documents To comply with the internal quality system while performing any activity To co-ordinate with cross functional departments like ADD RA CQA Plant for project product related activity

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    Tandalja, Vadodara, Gujarat, India Sun Pharmaceutical Industries, Inc. Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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