Executive - Mstg (Apply in 3 Minutes)

3 weeks ago

Vadodara Gujarat, India Sun Pharmaceutical Industries Full time

Job Title Senior Executive Executive - MSTG Non-Orals Business Unit R D1 Regulatory Affairs Job Grade G12A G11B 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 JOB DESCRIPTION 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 Conduct Gap assessment between R D and target manufacturing sites and prepare Gap assessment executive summary for review Equipment utilities SOPs Process Modelling Robustness and Optimization PRIMARY Use tools like QbD DoE and PAT to model and simulate processes before transfer Preform multivariate data analysis to assess robustness 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 Continuous Improvement CFT Reduce cycle time enhance robustness using Lean Six sigma Support to QA Regulatory CFT Provide technical input for regulatory inspections response to deficiencies and audit queries Development Related Travel Estimate NA Job Requirements Educational Qualification Graduate M Pharm Experience Tenure 3-7 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 Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees as assigned to this job Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent s

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