Senior Executive

Job Responsibilities:
- Device development and establishing device functional tests
- Compile Design History Files for drug-device combination products & Complete device design documentation
- Monitor & provide technical support during trials, scale-up, exhibit, and commercial batches.
- Develop testing procedures for new packaging materials.
- Prepare and review machine trial protocols, technology transfer documents, and labelling artworks.
- Packaging development & Artwork review & management activities for sterile / injection products
- Prepare specifications, trade dress, SOPs, study protocols/reports, code creation, bill of material, batch packaging records, and master packaging cards.
- Initiate vendor qualification, change controls, and material code creation.
- Coordinate with vendors and procurement for drawings, samples, and packaging materials.