Deputy Manager, Technical Writing

Amneal Pharmaceuticals LLC; Gujarat; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Technical Writing & Documentation professional to lead the creation and maintenance of documentation for complex R&D projects, including BFS processes and regulatory submissions.

You will standardize templates, work with SMEs to capture technical information, and ensure inspection readiness for regulatory audits. The role is based in Ahmedabad, India, within a dynamic development/manufacturing environment.

Qualifications

• Bachelor's degree in a science/engineering field.

Responsibilities

• Lead the preparation of comprehensive documentation for complex R&D projects, including new formulations, emerging technologies, and high-priority development programs.
• Prepare and maintain documentation for BFS (Blow-Fill-Seal) projects with detailed process descriptions, validation protocols/reports, and regulatory submission materials, ensuring GMP compliance.
• 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 and Packaging.
• Standardize and optimize documentation templates and workflows for clarity and compliance.
• Collaborate with SMEs to capture complex scientific information accurately.
• Create knowledge-sharing materials such as technical briefs, training guides, and white papers.
• Support regulatory inspections and audits to ensure inspection-readiness and GMP compliance.
• Monitor and implement industry best practices in technical writing and documentation.
• Lead or participate in special R&D projects including technology transfers and process improvements.
• Document innovative research outcomes and summarize findings for internal and regulatory use.
• Coordinate cross-functional project deliverables for pilot studies and scale-ups.
• Develop templates, tools, and knowledge bases to streamline project documentation.
• Support IP documentation and patent submissions with technical descriptions and data summaries.

Education

Bachelor's Degree

Job description

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.

Qualifications

Bachelor's Degree

Location

901-911,9th Floor,, Ahmedabad, GJ, 380051, IN