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 explicit, 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:

📌 Assistant Manager, Technical Writing (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad