Executive - FRD Non-Orals

3 days ago

India Sun Pharmaceutical Industries - Full time ₹ 12,00,000 - ₹ 36,00,000 per year


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."

Job Description

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 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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