Executive, Technical Writing

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 600,000 - 950,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a technical documentation professional to prepare, develop, and maintain documents ensuring cGMP compliance. The role collaborates with manufacturing, quality, regulatory, and engineering teams to translate technical information into compliant documentation.

You will conduct audits, review existing materials for gaps, and manage the document control lifecycle from creation through archival, maintaining accurate revision histories and change logs.

Responsibilities

• 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 clear, compliant documentation
• Review existing documentation to identify gaps, inconsistencies, or areas requiring update and elevate 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 Good 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.

Job description

• 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 clear, compliant documentation
• Review existing documentation to identify gaps, inconsistencies, or areas requiring update and elevate 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 Good 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.