Research Scientist
Year Ahmedabad, Gujarat, India
Job Description
b'
Division
PTC - MORAIYA
Job posted on
Jun 06, 2024
Employee Type
P-P5-Probationer-R&D Staff
Experience range (Years)
0 - N.A.
Please enter job description
- Characterizing materials and developing/qualifying packaging systems (primary, secondary, and tertiary).
- Completing design control deliverables and supporting relevant regulatory requirements for submission.
- Providing post-launch troubleshooting support for complex products.
- Developing drug delivery devices like Pen Devices, Auto Injectors, DPI, and pMDI with a complete understanding of regulatory expectations.
- Compiling documents such as URS, design control/history file for combination products.
- Performing functional performance studies of devices.
- Coordinating with vendors for the execution of non-disclosure agreements.
- Finalizing trade dress.
- Sourcing new packaging materials and developing new vendors.
- Tracking packaging material availability and procurement.
- Supporting COD and COG evaluation.
- Preparing lab notebooks and Packaging Development Reports.
- Handling submission/exhibit batches with supervision on the shop floor.
- Preparing BOMs (Bill of Materials) and batch Packaging Records for the EB, filing, and commercial batches.
- Preparing specifications, standard test procedures for various packaging material components, SOPs, and guidelines.
- Troubleshooting and effectively rectifying issues related to process and usage of packaging materials.
- Conducting SAP-related activities, change control, and other documentation.
- Responding to packaging-related queries in FDA deficiency.
- Designing pack configurations for commercial launch as per marketing requirements and conducting transportation studies.
- Revising artworks for RLD changes.
- Revising pack configurations as per marketing needs/cost optimization/automation.
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Job Detail
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Job IdJD3331921
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationAhmedabad, Gujarat, India
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EducationNot mentioned
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ExperienceYear