Amneal is hiring for the position of Senior Executive – Drug Device Combination Product | Product Delivery Development in Ahmedabad, Gujarat. The role focuses on drug-device combination product development, design controls, regulatory compliance, risk management, technical documentation, and coordination with cross-functional teams.
Candidates with a B.Pharm qualification and 5–8 years of experience can consider this opportunity. An M.Pharm qualification is preferred.
Job Details
| Particulars | Details |
|---|---|
| Company | Amneal |
| Job Title | Senior Executive – Drug Device Combination Product |
| Department/Function | Product Delivery Development |
| Job Location | Ahmedabad City, Gujarat, India |
| Qualification | B.Pharm required |
| Preferred Qualification | M.Pharm |
| Experience | 5–8 years |
| Industry | Pharmaceutical |
| Job Type | Executive Role |
Position
Senior Executive – Drug Device Combination Product Development
The selected candidate will support the development and compliance of drug-device combination products, including design documentation, quality management, risk assessment, design transfer, and coordination with external development and testing partners.
Job Responsibilities
- Review change controls related to drug-device combination products (DDCPs).
- Prepare and review study protocols, reports, and test procedures in accordance with Quality Management System Regulation (QMSR) requirements.
- Apply knowledge of QMSR, ISO/ASTM standards, and medical device design controls.
- Coordinate with Quality Management and cross-functional teams to compile Design History Files (DHFs).
- Ensure compliance with established quality management system requirements for combination products.
- Help prepare threshold and comparative analyses, along with human factors study protocols.
- Support the identification, preparation, and compilation of design transfer documents.
- Prepare risk management documentation in accordance with ISO 14971.
- Coordinate with device development suppliers, third parties, and testing institutions.
- Support product development activities while maintaining regulatory compliance and technical documentation requirements.
Eligibility and Qualifications
Candidates should meet the following requirements:
- Educational qualification: B.Pharm is required.
- Preferred qualification: M.Pharm.
- Experience: 5–8 years.
- Familiarity with drug-device combination product development and regulatory requirements.
- Knowledge of design controls, quality management systems, and relevant ISO/ASTM standards.
- Ability to collaborate with cross-functional teams and manage technical documentation.
Required Skills
Amneal is looking for candidates with skills in the following areas:
- Cross-functional collaboration
- Data integrity and documentation security
- Process monitoring and control
- Process optimization
- Product characterization and testing
- Product lifecycle oversight
- Quality by Design (QbD) implementation
- Regulatory compliance
- Stakeholder management
