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 explicit, 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 Positive 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:

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