Responsibilities
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.
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 Packaging documentation like Pack Style, Justification Report etc. as per Product/Regulatory requirements
Qualification & Experience
Qualification : B.sc / B.Pharm / M.Pharm with PG Dip in Packaging Development
Experience : 5 – 10 years as a Packaging Scientist in Pharmaceutical Co.
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