Amneal Pharmaceuticals

Manager, Formulation & Development

Amneal Pharmaceuticals  •  Republic of India (Onsite)  •  9 days ago
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Job Description

Key Responsibilities

  • Author and maintain Design History File (DHF) documentation, including user needs, design inputs/outputs, and verification & validation records.
  • Prepare and review QMS documents — SOPs, work instructions, technical reports, and change controls — in line with ISO 13485 and applicable regulations.
  • Draft development reports, design verification/validation reports, and human factors (formative & summative) reports supporting device safety and usability.
  • Support risk management activities (dFMEA / pFMEA, hazard analysis, risk management file per ISO 14971).
  • Contribute to design verification/validation testing and test-method/protocol development for device functional performance (e.g., dose accuracy, injection time, force testing).
  • Support regulatory submissions and interface with cross-functional teams (Quality, Regulatory, R&D) and external testing labs/vendors.

Maintain documentation traceability, design controls, and change-control records within the document management system

Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.

Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.

Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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