Title:  Manager

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/review 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/review product development protocol & report for different development studies.

8. To prepare/review test request for analysis of raw material (API/Excipients) & drug product.

9. To prepare/review stability protocol & report.

10. To prepare budget of assigned project.

11. To prepare/review tech-transfer documents (e.g.sheet II, MF, RA, FMEA, stability plan, scale up report and SDS)

12. To support in execution of scale up /exhibit /clinical batches at plant/CMO

13. To prepare/review documents required for regulatory submission for all markets & to prepare/review technical reports/scientific justification to respond regulatory queries.

14.  To prepare/review SOPs for laboratory equipment/instrument.

15. To prepare/review troubleshooting/investigational reports for failures/OOS/OOT.

16. To ensure compliance of internal quality system