Job Title Manager 2 - MSTG Non Orals Business Unit R D1 Regulatory Affairs Job Grade G11A Location Baroda At Sun Pharma we commit to helping you Create your own sunshine - by fostering an setting 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 Process Development and Optimization Support PRIMARY Partner with formulation scientists to ensure manufacturability and scale up feasibility Translate lab-scale batch data into pilot scale-up strategies Identify and define critical process parameters CPPs and key process parameters KPPs Partner with FDD for process risk assessment e g FMEA Partner with Process engineering MSTG FDD and Conduct Scale Up studies and develop scale up model Technology transfer documentation PRIMARY Prepare tech transfer packages Process Optimization report 2 Conduct Gap assessment between R D and target manufacturing sites and prepare Gap assessment executive summary for review Equipment utilities SOPs Control strategy design PRIMARY Develop initial control strategies Process Modelling Robustness and Optimization PRIMARY 1 Use tools like QbD DoE and PAT to model and simulate processes before transfer 2 Preform multivariate data analysis to assess robustness 3 Exploration of PAT Digital tools for non-oral portfolio processes Analytical Method understanding CFT Collaborate with Analytical R D for method robustness and comparability during transfer Support Regulatory fillings CFT Provide data and technical justification for regulatory submissions Troubleshooting and Investigations Scale up EBs PRIMARY Address deviations out of spec OOS and process failure with root cause analysis

📌 Manager -2 Mstg (Vadodara)
🏢 Sun Pharmaceutical Industries
📍 Vadodara