Senior Manager

Role & responsibilities

1. Characterization of RLD pack samples.

2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement.

3. Identification of new packaging material & new vendor development for packaging materials.

4. Mold development for primary packaging material & secondary packaging material & its validation.

5. Support to Regulatory team on ANDAs/NDA’s filling for regulated market.

6. Coordination with NPI & planning team for launch of ANDA’s/NDA’s.

7.Preparation & revision of packaging material specification.

8. Preparation & review of MPC, FMEA, TA, DHF & AFMEA.

9. Preparation & review of Development Study protocol & report & execute the study.

10. Performing functional test as per regulatory requirement.

11. Coordination with Cross functional team like (FDD/RA/Plant/Marketing/PMO) for completion of task.

12. Participating in FAT of machines.

13. Support to plant for validation, trouble shooting and market complaints.

14. SOP preparation, periodic review and packaging lab equipment handling/maintain calibration records.

15. Preparation of Packaging documentation (Pack Style, Justification Report etc. as per Product/Regulatory) as required.

16.Handling of primary and secondary packaging material in storage area & maintaining the PM quantity for stability packaging at R&D.