Deputy Manager, Technical Writing
Job Description
Job Responsibility:
Technical Writing & Documentation: Development Key Responsibilities
- Lead the preparation of comprehensive documentation for complex R&D projects, including new formulations, emerging technologies, advanced process studies, and high-priority development programs
- Prepare and maintain documentation for BFS (Blow-Fill-Seal) projects, including detailed process descriptions, validation protocols/reports, and regulatory submission materials, ensuring full compliance with aseptic processing and GMP standards.
- Draft and review technical assessment reports and deviation investigations.
- Handle, change controls, unexpected deviations, product defects, and event investigations.
- Update and maintain databases and status trackers for Operations, Packaging.
- Ensure completion of all assigned trainings and maintain records of compliance.
- Standardize and optimize documentation templates and workflows to improve clarity, compliance, and efficiency across R&D and manufacturing.
- Collaborate with subject matter experts (SMEs) to capture complex scientific and technical information accurately.
- Create knowledge-sharing materials, including technical briefs, training guides, and white papers.
- Support regulatory inspections and audits by ensuring all documents are inspection-ready and compliant with GMP guidelines.
- Monitor and implement industry best practices in technical writing and documentation.
- Lead or participate in special R&D projects, including technology transfers, process improvement initiatives.
- Document innovative research outcomes and summarize findings for internal and regulatory use.
- Coordinate cross-functional project deliverables for pilot studies, scale-ups, or technology adoption projects.
- Develop templates, tools, and knowledge bases to streamline special project documentation.
- Support intellectual property documentation and patent submissions by preparing technical descriptions and data summaries.
Bachelor's Degree