Technical Writer - Production

SUMMARY:

Technical Writer- Production is responsible for creating, managing, and maintaining high-quality documentation that supports manufacturing operations and ensures compliance with regulatory requirements. The Technical Writer will play a critical role in supporting CAPA, deviation handling, and investigation reports within the production environment.

EDUCATIONAL QUALIFICATION:

• Bachelor’s degree in science, Engineering, Technical Writing, or a related field.
• 2+ years of experience in a manufacturing, pharmaceutical, or regulated industry.
• Strong understanding of CAPA, deviation, and investigation processes.
• Excellent written and verbal communication skills.
• Familiarity with electronic quality management systems (eQMS).
• Proficiency with Microsoft Office Suite and document management systems.
• Familiarity with cGMP and other regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop, write, and maintain clear, concise, and accurate production documentation including SOPs, batch records, work instructions, and protocols.
• Prepare and manage deviation reports, CAPAs, and manufacturing investigations in collaboration with cross-functional teams.
• Ensure all documentation meets internal standards and complies with cGMP, FDA, and other regulatory guidelines.
• Coordinate with production, quality, and compliance teams to gather technical information and ensure accurate documentation.
• Support audit readiness by maintaining up-to-date records and supporting documentation for inspections.
• Participate in root cause analysis and contribute to the implementation of corrective and preventive actions.
• Track and follow up on documentation-related action items to ensure timely closure.
• Assist in continuous improvement initiatives by identifying gaps and suggesting process enhancements.