R&D Packaging Development

1. Evaluation and identification of Innovator packing configuration.

2. Work closely with formulation teams for pharmaceutical dosage forms sensitivity and dimensional study, to evaluate packaging requirement, packing material optimization, component selection and material development.

3. Preparation of Trade dress based on the innovator packaging configuration.

4. Preparation of specifications and standard test procedures for packaging material/ component.

5. Initiation of design and procurement of change part, packaging equipment and packaging material/ component in coordination with R&D.

6. Planning and supervision of GMP batch pertaining to packaging.

7. Preparation of Bill Of material and Master packaging Record for exhibit and commercial batches.

8. Support to plant packing in addressing technical packaging challenge.

9. Support to regulatory during filing process and query response.

10. Technical Support to plant during Commercial launch.

11. Coordination with BD, Marketing and Third part associate for finalization of packaging related activities.

12. Coordination with SCM and Vendor for suitable packing materials.

13. Preparation of SOPs for new equipments at R&D, procedure for operational requirement and mandatory revision on the existing procedure.

14. Participate in project team meeting as and when required.

15. Preparation of packaging development report as per regulatory requirement.

16. Packaging material testing, analysis and identification whenever required.

17. Designing and execution of packaging trial as and when required.