Title:  Exe

M.Pharm (Pharmaceutics) with about 5 - 7 yrs experience in Formulation R&D product development with experience in injectable product development includes liquid, lyophilized and complex injectables.

1.   To conduct Literature search and Patent search for assigned project.

2.   To procure raw materials (API / excipients), packaging materials and innovator samples in consultation with packaging/purchase department.

3.   To prepare application for form 29 and form 11 for the grant of manufacturing license for the purpose of Examination, Testing and Analysis and import of RLD.

4.   To perform pre - formulation and formulation development trials with QbD approach and therefore to develop a robust formulation.

5.   To manufacture batches for stability studies and write experiments in Laboratory Notebook.

6.   To prepare Technology Transfer documents like MF, Development Study Report, Risk Assessment and FMEA.

7.   To review analytical reports and prepare compilation sheet and discuss results with superior.

8.   To co-ordinate with cross functional departments like ADD, RA, QA, Plant for project / product related activity.

9. To prepare SOP's related to systems and laboratory equipment's

10. To be familiar of regulatory guidelines.

11. To execute scale up/ exhibit batches.

12. Comply with the systems and SOP’s while execution of experiments.

13. To prepare stability protocol and load the stability batches

14. Review the stability batches data and report preparation.

15. Preparation of specification proposal with justifications

16. Preparation of product development report (PDR), elemental risk assessment report and Nitrosamine risk assessment report

17. Address the regulatory queries