Zydus Group Job Vacancy Details:
Zydus Group Job Vacancy For Packaging Development (Formulation R&D) Dept |
Inviting candidates for the post of Sr. Executive / Assistant Manager for Packaging Development (Formulation R&D) department for Pharmaceutical Technology Centre, Ahmedabad
Packaging Development (Formulation R&D)
Bachelor’s degree and Diploma in Packaging with 3-7 years of experience in the field of Packaging Development for US Market.
Candidates will be responsible for the development of drug delivery devices and packaging of Injectable / Topical / Inhalation products. This includes activities related to development, execution support for exhibit batches, support for regulatory submission, commercial launch, and maintaining the product life cycle, as briefed below:
• 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.
Candidates would be responsible for the following tasks:
• 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.
Candidates would also be responsible for the following tasks:
• Responding to packaging-related queries in FDA deficiency.
• Designing packed 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.
Candidates should possess the following skills:
• Should be able to manage multiple projects in a cross-functional environment.
• Should have good communication skills, both written and oral and should be proficient in preparing technical reports and presentations.
How to Apply Zydus Group Job
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