Sr. Officer

Year Vadodara, Gujarat, India

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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 material
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
Preparation & review of Development Study protocol & report & execute the study.
Performing functional test as per country 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 activities
Support to plant for market complaints
Preparation of Packaging documentation like (Pack Style, Justification Report etc as per Product/Regulatory) requirements
Handling of primary and secondary packaging material in storage area & maintaining the PM quantity for stability packaging at R&D.

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