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.
