Senior Manager - 1

ConfidentialVadodara, India

5 days ago

Job description

Characterization of RLD pack samples.

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

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

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

Support to Regulatory team on ANDA's / NDA's filling for regulated market.

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

Preparation & revision of packaging material specification.

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

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

Performing functional test as per regulatory requirement.

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

Participating in FAT of machines.

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

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

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

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

Skills Required

Fmea

Senior Manager • Vadodara, India