- Responsible for reviewing all projects for packaging material and new development activities.
- PIF evaluation and Literature Review for current 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.

Education Qualification: B. Pharmacy or M. Pharmacy

Experience: Minimum 5 years in relevant job profile.

📌 Senior Research Associate (India)
🏢 DIFGEN PHARMACEUTICALS PRIVATE
📍 India