Senior Executive, Drug Device Combination Product | Product Delivery Development

Amneal Pharmaceuticals · Ahmedabad

Description:

This role is responsible for developing and optimizing pharmaceutical packaging systems by applying scientific and engineering principles to ensure product protection, stability, compliance, and patient usability. The role contributes to design, selection, and qualification of primary and secondary packaging components aligned with product requirements, regulatory standards, and commercial considerations. The incumbent leads packaging development studies including compatibility, stability, and performance evaluations, and supports packaging validation and technology transfer activities. It collaborates with cross-functional teams to ensure timely and compliant product delivery. The role also evaluates new packaging technologies and materials, contributing to innovation, cost optimization, and continuous improvement within the product development lifecycle.

Responsibilities:

Familiarity in the area of drug-device combination product development and regulatory requirements
- Review change controls pertaining to DDCPs
  - Knowledge of QMSRs and ISO/ASTM standards including design controls for devices
    - Ability to work with cross-functional teams
    - Prepare and/or review DDCP documents including study protocols, reports, test procedures as per the QMSR requirements.
    - Coordinate with cross-functional teams including Quality Management and compile various elements of DHFs (Design History Files) for drug device combination products.
    - Ensure conformance to the established Quality Management Systems Regulations for combination products.
    - Help draft Threshold/Comparative Analysis and Human Factors Study protocols
    - Provide support for identifying, preparing, and compiling the design transfer documents.
    - Prepare the risk management documents as per ISO 14971.
    - Interact with device development suppliers/third parties’/testing institutions for the development of drug device combinations products as per the requirements.

Additional Responsibilities:

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

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