Essential Functions:

- Lead the preparation, development, and maintenance of technical documents including standard operating procedures, work instructions, technical reports, and related materials in compliance with cGMP and regulatory requirements
- Establish documentation metrics and dashboards to track quality, compliance trends, and team productivity
- Collaborate with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into transparent, compliant documentation
- Review and approve existing documentation to identify gaps, inconsistencies, or areas requiring update and escalate findings to relevant stakeholders
- Ensure all technical documents accurately reflect manufacturing processes, equipment operations, and quality systems
- Provide guidance and review support to junior documentation staff on documentation standards and cGMP requirements
- Manage the document control lifecycle including creation, revision, review, approval, and archival of technical documents




- Maintain accurate and complete documentation records including document revision histories and change control logs
- Ensure all technical writing activities comply with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements
- Participate in process improvement projects and functional team initiatives to enhance documentation quality, efficiency, and compliance
- Prepare Process and Cleaning Validation Protocol and Reports

Additional Responsibilities:

Education:

- B. Pharm B. Pharm - Required

- M. Pharm M. Pharm - Preferred

Experience:

- 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Executive, Technical Writing (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad