Amneal Pharmaceuticals

Assistant Manager, Technical Writing

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  1 day ago
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Job Description

Essential Functions:

  • Manage and coordinate technical writing activities for manufacturing SOPs, batch records, work instructions, and other GMP-critical documents
  • Implement and manage electronic document management systems to improve document accessibility and control efficiency
  • Translate complex manufacturing processes and technical information into clear, accurate, and compliant technical documentation
  • Review and revise existing technical documents to ensure accuracy, completeness, and alignment with current regulatory requirements and manufacturing practices
  • Develop and implement documentation schedules and workflows to ensure timely creation and revision of technical documents across manufacturing areas
  • Ensure all technical documents comply with applicable regulatory requirements including FDA, EMA, and other relevant authorities
  • Collaborate with manufacturing, quality assurance, and regulatory affairs teams to ensure technical documents accurately reflect processes and regulatory expectations
  • Identify documentation gaps and initiate corrective actions to address them in a timely manner
  • Train manufacturing personnel on technical writing standards and GMP documentation best practices
  • Lead participation in process improvement projects to develop methods and procedures that enhance documentation quality and standardize technical writing practices.

Education:

  • B. Pharm B. Pharm - Required
  • M. Pharm M. Pharm - Preferred

Experience:

  • 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses:

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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