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Assistant Manager, Technical Writing

Assistant Manager, Technical Writing

Amneal Pharmaceuticals
8-10 Years
Not Disclosed
  • Posted 20 hours ago
  • Be among the first 10 applicants

Job Description

Essential Functions

JOB DESCRIPTION

  • 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

QUALIFICATIONS

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

Experience

  • 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses:

More Info

Job Type:
Industry:
Employment Type:

Key Skills

Electronic document management systems

Manufacturing SOPs

Documentation schedules and workflows

GMP-critical documents

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