Job Description

This role is responsible for managing and coordinating technical writing activities within a pharmaceutical manufacturing environment, ensuring that all standard operating procedures, batch records, work instructions, and other technical documents are developed, reviewed, and maintained in strict compliance with regulatory requirements and Good Manufacturing Practices. The incumbent applies specialized writing skills to translate complex manufacturing processes and technical information into clear, accurate, and compliant documentation. The position requires a thorough understanding of GMP documentation standards and regulatory requirements to ensure that all technical documents support product quality and regulatory compliance. The role involves developing and implementing documentation schedules and workflows to ensure the timely creation and revision of technical documents across manufacturing areas. The incumbent is accountable for identifying documentation gaps and ensuring that all technical writing activities meet quality and compliance objectives. The position contributes to process improvement initiatives aimed at enhancing documentation quality, standardizing technical writing practices, and optimizing documentation workflows. The role also involves collaborating with cross-functional teams to ensure that technical documents accurately reflect manufacturing processes and regulatory expectations.

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

Additional Responsibilities: Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses: