DIFGEN PHARMACEUTICALS PRIVATE LIMITED

Discussion

Senior Research Associate

Open 21d
  • Responsible for reviewing all projects for packaging material and new development activities.
  • PIF evaluation and Literature Review for new products.
  • Review and Approval of RLD/Innovator packaging material analysis and characterization

reports.

  • Review and Approval of trade dress and packaging Developments reports.
  • Proposing primary and secondary packaging materials for new products
  • Sourcing of packaging materials and vendor finalization .
  • Review and Approval of Specifications and STP for packaging materials.
  • Review and Approval of master packaging cards (MPC) .
  • Review and Approval of Bill of materials for packaging materials.
  • Review of CFT/CMO documents (BPR/IBPR/BMR).
  • Review and Approval of Threshold analysis reports and DHF documents (URS, DDP, Design

Input, Design Output, Design Verification, Design Validation, Design Review, Design transfer, etc.).

  • Review and Approval of protocols for in-house and external lab testing for packaging

materials.

  • Coordination with CFT teams and customers for smooth documentation .
  • Coordination with CMO for smooth execution of Scaleup and Exhibit batches.
  • Coordination with suppliers for layout/ change parts development .
  • Review and Approval of Change Controls for documentation .
  • Preparation of Packaging Development SOP's.
  • Preparation of bracketing sheets for container closure system and generation of protocol-

based packaging functionality studies and design qualification studies.
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