Manager-1

1 week ago


Vadodara, Gujarat, 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/ATP's
  • 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
  • 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
  • Knowledge of various ISO/ASTM standards & understanding of medical device regulations applicable for combination product for US & EU market
  • Cost Saving & Innovation

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    2 weeks ago


    Vadodara, Gujarat, India Sun Pharmaceutical Industries Ltd Full time

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    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....

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