Manager-1

18 hours ago

Vadodara, India Sun Pharmaceutical Industries Ltd Full time

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/PPIC/Marketing/BD/PMO for completion of task
- Participating in FAT of machines
- Handling of Medical Devices, injectables and characterization.
- Preparation of Threshold Analysis and URRA.
- 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

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