Senior Executive, Drug Device Combination Product | Product Delivery Development
Amneal Pharmaceuticals
JOB 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.
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years
About Us
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.
About The Team
The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key Roles That The Human Resources Team Performs
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.