- 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.
UG/PGEducation Qualification: B. Pharmacy or M. Pharmacy
Experience: Minimum 5 years in relevant job profile.
Skills Required
- B. Pharmacy or M. Pharmacy
- Minimum 5 years in relevant job profile
What We Do
DifGen Pharmaceuticals is a US-based global pharmaceutical company specializing in the development and manufacturing of complex, high-barrier-to-entry generic and specialty pharmaceutical products. The company focuses on creating dependable solutions in product development and commercialization to increase accessibility to high-quality medications, thereby leading to the creation of next-generation healthy communities.
