Executive - Frd Non-orals

4 days ago

Vadodara Gujarat, India Sun Pharmaceutical Industries Full time

Job Title Executive - FRD Non-Orals Business Unit R D1 Regulatory Affairs Job Grade 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 Key Responsibilities Experience in Formulation R D product development with experience in injectable product development in Novel drug delivery systems Lyophilized product Solution product To do literature search relevant to projects requirement and understanding of Regulatory guidance To procure raw materials API excipients packaging materials and Reference product in consultation with packaging purchase department To prepare request application for Testing analysis license for new product Reference product To design conduct pre-formulation and formulation developmental experiments with QbD approach and to enter the details about drug product manufacturing experiments in Lab Notebook To prepare TR IOM for the respective API Excipients product sample analysis To prepare product development stability study protocols and reports prepare SOPs for related laboratory equipment instrument and maintain critical data records for regulatory audits To prepare document for Technology Transfer like sheet II Master Formula Risk assessment based upon CPP CQA FMEA and SDS Group work for lab management handling instrument common group activities and co-ordination with cross functional teams for handling projects issue To support cross functional activities at plant for Scale- up Exhibit batches commercial batches and new assignments Preparation of Product development report PDR Risk assessment reports and do compilation of project issues To comply with the internal quality system while performing any activity Travel Estimate NA Job Requirements Educational Qualification Graduate M Pharm Experience Tenure 2-4 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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