Job Description
- Prepare/review/approve various documents required as per design control procedures (21 CFR 820.30) of design and development of drug device combination product.
- Identify, prepare/arrange, review, approve and compiling the documents of various development stages of the drug device combination product.
- Compilation of DHF (Design History File) for drug device combination products.
- To prepare the development related documents as per the current status of the drug device combination products as per the 11608.
- Support for the Threshold Analysis and Risk Management activities as per ISO 14971.
- Support to RA for required documents during regulatory submissions for all markets as per the applicable guidance.
- Support for various testing like performance testing, human factor studies.
- Support for identifying, preparing, and compiling the design transfer documents.
- Writing reports and documentation, creating test procedures as an when required.
- Support engineering activities as required including defining product requirements, generating design concepts, prototyping, writing test protocols and reports, participating in risk and hazards management activities, design verification and design transfer.
- Designing test methods, writing, and conducting test protocols, and generating test reports for medical devices.
- To prepare the risk management documents as per ISO 14971.
- To prepare and approve the risk assessment and control activities.
- Responsible for planning, monitoring, and defining validation strategies, defining acceptance criteria, selection of appropriate test methods, execution of validation tests, and reviewing results.
Qualifications
Master's Degree
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.
