Essential Functions:
Prepare, develop, and maintain technical documents including standard operating procedures, work instructions, technical reports, and related materials in compliance with cGMP and regulatory requirements
Conduct periodic document audits to ensure ongoing compliance, traceability, and alignment with evolving regulatory requirements
Collaborate with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into explicit, compliant documentation
Review 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
Support 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
Support training activities related to technical documentation standards and cGMP requirements as required.

Education:
B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred

Experience:
5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

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