Manager, Formulation & Development
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 23d ago
About a minute. You'll make an account on the way through.
About this role
Key Responsibilities
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Author and maintain Design History File (DHF) documentation, including user needs, design inputs/outputs, and verification validation records.
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Prepare and review QMS documents - SOPs, work instructions, technical reports, and change controls - in line with ISO 13485 and applicable regulations.
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Draft development reports, design verification/validation reports, and human factors (formative summative) reports supporting device safety and usability.
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Support risk management activities (dFMEA / pFMEA, hazard analysis, risk management file per ISO 14971).
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Contribute to design verification/validation testing and test-method/protocol development for device functional performance (e.g., dose accuracy, injection time, force testing).
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Support regulatory submissions and interface with cross-functional teams (Quality, Regulatory, RD) and external testing labs/vendors.
Maintain documentation traceability, design controls, and change-control records within the document management system
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.
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About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
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