About this role
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: