Deputy Manager, Technical Writing at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

13 Jul, 26

Salary

0.0

Posted On

14 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Writing, Documentation, GMP Standards, Aseptic Processing, Validation Protocols, Regulatory Submission, Project Management, R&D, Change Control, Deviation Investigation, Process Improvement, Technology Transfer, Quality Assurance, Data Analysis, Cross-functional Collaboration, Intellectual Property

Industry

Pharmaceutical Manufacturing

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.

Responsibilities

The Deputy Manager will lead the preparation of complex technical documentation for R&D and BFS projects while ensuring compliance with GMP and regulatory standards. They will also supervise project managers, monitor project milestones, and facilitate cross-functional coordination to ensure successful project execution.