Title:  Executive - Packaging & Medical Devices

Job Description:

1. Characterization of RLD Pack samples for injectable, ophthalmic and inhalation products.
2. Finalization of pack configuration for exhibit batches of new generic products/ NDA products as per requirement.
3. Identification of new packaging materials and new vendor development for packaging materials.
4. Mold development for primary & secondary packaging materials and its validation.
5. Support to regulatory team for ANDA’s / NDA’s filling for regulated market & support for query response.
6. Coordination with NPI and planning team for launch of ANDA’s / NDA’s
7. Preparation and revision of packing material specifications.
8. Preparation and review of MPC and FMEA.
9. Preparation and review of development study protocol, report and execute the study.
10. Performing functional tests for pack as per country requirements.  
11. Participate in FAT of Machines.
12. Support to plant for validation and troubleshooting activities.
13. Support plant in market complaints.
14. Preparation of packaging documents like Pack Style, Justification report as per product/ regulatory requirements.
15. Coordination with cross functional team like FDD/RA/Plant/PPIC/Marketing/BD/PMO for completion of task.

olving skills.