Research Scientist
2 weeks ago
Department
- PTC - MORAIYA
- Job posted on
- May 31, 2023
- Employment type
- P-P5-Probationer-R&D Staff
- Characterizing materials, developing and qualifying packaging systems (primary, secondary, and tertiary), completing design control deliverables, supporting relevant regulatory requirements for submission, and providing post-launch troubleshooting support for complex products.
- Development of the drug delivery devices with a comprehensive understanding of regulatory expectations.
- Supporting the compilation of documents such as URS and design control/history files for combination products.
- Performing functional performance study of the devices.
- Coordinating with vendors to execute non-disclosure agreements.
- Trade dress finalization.
- Sourcing of new Packaging materials, new vendor development & tracking of Packaging Components.
- COD and COG evaluation support
- Packaging Development Report preparation.
- Supervision at shop floor for smooth execution of the submission batches.
- Preparing Bill of Materials (BOMs) and batch packaging records for the exhibit batches, filing, and commercial batches.
- Preparing specifications, standard test procedures for various packaging material components, standard operating procedures (SOPs), and guidelines.
- Troubleshooting and effectively rectifying issues related to process and usage of packaging materials.
- Performing SAP related activities, change control, and other documentation.
- Responding to packaging related queries in FDA deficiency letters.
- Designing the pack configuration for commercial launch as per the marketing requirement and conducting transportation study.
- Revising artwork as per RLD changes.
- Revising pack configuration as per marketing needs, cost optimization, or automation.
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