Assistant Manager, Drug Device Development
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 41d ago
Undisclosed8–10 yrsfulltimeSourced from
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About this role
Description:
Key Responsibilities - Lead the development, organization, and maintece of Design History File (DHF) documentation in compliance with 21 CFR 820.30, combination product requirements, and internal procedures
- Author and technically own key design control deliverables, including design inputs, system requirements, design outputs and specifications, verification and validation protocols, reports, and design review documentation
- Ensure robust traceability between user needs, drug-device interfaces, risk controls, design outputs, and verification and validation activities
- Collaborate with cross functional teams such as RD, Analytical, Quality, manufacturing, CMC and Regulatory Affairs to ensure consistent technical intent across development artifacts
- Capture design rationale and engineering decisions in a clear, defensible manner suitable for regulatory review
- Support integration of device development activities within broader drug development timelines and program milestones
- Assess and manage documentation and technical impacts of design changes throughout development and lifecycle management
- Participate as a technical contributor in risk management activities, design reviews, and cross-functional working sessions
- Support inspection and audit readiness by ensuring DHF completeness, clarity, and consistency across combination product documentation
- Bachelors Degree (BA/BS) B. Sc. - Required
- Master Degree (MS/MA) M.Sc. - Preferred
- 8 years or more in 8 - 10 Years
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Cfrdrug developmentProduct Documentationverification and validationRegulatory AffairsbsDesign History fileRisk ManagementManufacturingmaintenancecompliance
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
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Culture
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