Packaging Development - Topical and Nasal

As an R&D Executive at PTC - MORAIYA, your role involves characterizing materials and developing/qualifying packaging systems, including primary, secondary, and tertiary packaging. You will be responsible for completing design control deliverables, supporting relevant regulatory requirements for submission, and providing post-launch troubleshooting support for complex products. Your tasks also include developing drug delivery devices like Pen Devices, Auto Injectors, DPI, and pMDI while ensuring a comprehensive understanding of regulatory expectations. Key Responsibilities: - Compile documents such as URS and design control/history file for combination products - Perform functional performance studies of devices - Coordinate with vendors for the execution of non-disclosure agreements - Finalize trade dress and source new packaging materials from developing new vendors - Track packaging material availability and procurement - Support COD and COG evaluation - Prepare lab notebooks and Packaging Development Reports - Handle submission/exhibit batches with supervision on the shop floor - Prepare BOMs and batch Packaging Records for EB, filing, and commercial batches - Prepare specifications, standard test procedures for various packaging material components, SOPs, and guidelines - Troubleshoot and rectify issues related to process and usage of packaging materials - Conduct SAP-related activities, change control, and other documentation - Respond to packaging-related queries in FDA deficiency - Design pack configurations for commercial launch as per marketing requirements and conduct transportation studies - Revise artworks for RLD changes and pack configurations as per marketing needs, cost optimization, and automation Qualifications Required: - Bachelor's degree in a related field (e.g., Packaging Engineering, Materials Science) or equivalent work experience - Knowledge of regulatory requirements for packaging materials and drug delivery devices - Strong attention to detail and problem-solving skills - Ability to work effectively both independently and in a team environment - Proficiency in SAP and other relevant software applications - Excellent communication and organizational skills This job at PTC - MORAIYA offers you the opportunity to contribute to the development and qualification of packaging systems for various products, ensuring compliance with regulatory standards and supporting post-launch activities. Join us in our mission to deliver high-quality pharmaceutical products to the market.,