- Responsible for all Sterile and Nonsterile products for packaging material new development.
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PIF evaluation and Literature Review for new products
- RLD/Innovator packaging material analysis and preparation of characterization reports
- Preparation of trade dress and packaging Developments reports.
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Proposing primary and secondary packaging materials for new products
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Sourcing of packaging materials and vendor finalization.
- Preparation of Specifications and STP for packaging materials.
- Preparation of master packaging card (MPC)
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Preparation of Bill of materials for packaging materials
- Review of CFT/CMO documents (BPR)
- Preparation of Threshold analysis reports and DHF documents.
- Preparation of protocols for in-house and external lab testing for packaging materials.
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Coordination with CFT teams and customers for smooth documentation.
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Coordination with CMO for smooth execution of Exhibit batches.
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Coordination with suppliers for layout/ change parts development.
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Preparation of Packaging Development SOP’s
- Initiating Change Controls for documentation.
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Preparation of bracketing sheets for container closure system and generation of protocol-based packaging functionality studies and design qualification studies.
Diploma In Packaging Technology with 4 to 6 years of experience in R&D pharmaceutical packaging Development