Assistant Manager, Technical Writing

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: