Assistant Manager, Technical Writing

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