Executive, Technical Writing
Amneal Pharmaceuticals India · Ahmedabad
Source and collection record
Last observed by our collector: . This is not a manual review or a confirmation from the employer.
Employer requisition: 9074
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Collected role description
Description: This role is responsible for preparing, developing, and maintaining technical documentation within a regulated pharmaceutical manufacturing environment, ensuring that all technical documents including standard operating procedures, work instructions, technical reports, and related materials are accurate, clear, and compliant with current Good Manufacturing Practices and applicable regulatory requirements. The position supports the creation and revision of technical documents that describe manufacturing processes, equipment operations, and quality systems in a manner that is accessible and actionable for manufacturing personnel. It ensures that all technical writing activities are conducted in strict adherence to document control procedures and regulatory standards. The role collaborates with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into clear, compliant documentation. It performs reviews of existing documen 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 clear, 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 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.
Collected minimum qualification
Education: B. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred 5 years or more in 5 - 8 Years Specialized Knowledge: Licenses:
Collected experience requirement
5 - 8 Years