Executive - Frd Non-orals

5 days 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 1 To prepare execute metered dose inhaler MDI formulation development experiments 2 To design pre-formulation and prototype experiments and to monitor batches prepared for stability studies method development validation 3 To prepare documents for import of API Innovator sample and for manufacturing license for examination testing analysis of drug products 4 To ensure procurement of raw material API Excipients packing material innovator samples in consultation with packing Purchase department 5 To evaluate Innovator pack details and review Innovator procurement quantity with justification 6 To prepare product development protocol report for different development studies 8 To prepare test request for analysis of raw material API Excipients drug product 9 To prepare stability protocol report 10 To prepare tech-transfer documents e g sheet II MF RA FMEA stability plan scale up report and SDS 11 To support in execution of scale up exhibit clinical batches at plant CMO 12 To prepare documents required for regulatory submission for all markets to prepare review technical reports scientific justification to respond regulatory queries 13 To prepare review SOPs for laboratory equipment instrument 14 To prepare troubleshooting investigational reports for failures OOS OOT 15 To ensure compliance of internal quality system Travel Estimate NA Job Requirements Educational Qualification M Pharm Experience Tenure 2-6 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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