Senior Executive

4 weeks ago

Vadodara, Gujarat, India Sun Pharmaceutical Industries Full time

Job Title Senior Executive Executive - FRD Non Orals Business Unit R D1 Regulatory Affairs Job Grade G11B G12A Location Baroda At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll find yourself becoming Better every day through continuous progress Exhibit self-drive as you Take charge and lead with confidence Additionally demonstrate a collaborative spirit knowing that we Thrive together and support each other s journeys To design and conduct experiments for preformulation formulation optimization of Microsphere 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 prepare summary report and review 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 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 Travel Estimate NA Job Requirements Educational Qualification M Pharm Experience Tenure 3-6 years Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together

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