Senior Executive Technical Writing

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks an experienced Documentation Specialist to lead the creation and maintenance of SOPs, work instructions, and technical reports for cGMP-compliant manufacturing processes.

You will collaborate with manufacturing, quality, regulatory and engineering teams to gather information, review documents, and ensure accuracy and archival of records. Strong writing and regulatory discipline are essential.

Qualifications

• Experience in preparing and maintaining SOPs, work instructions, technical reports and related materials.
• Strong understanding of cGMP and regulatory expectations for documentation.
• Ability to translate complex manufacturing information into clear, compliant documents.

Responsibilities

• Lead the preparation, development, and maintenance of technical documents in line with cGMP and regulatory needs.
• Establish metrics and dashboards to track quality, compliance trends and team productivity.
• Collaborate with manufacturing, quality, regulatory and engineering teams to gather information for compliant docs.
• Review and approve existing documentation, identify gaps, and escalate findings as needed.
• Ensure documents reflect manufacturing processes, equipment operations, and quality systems.
• Provide guidance to junior staff on standards and cGMP requirements.
• Manage document control lifecycle including creation, revision, approval and archiving.
• Maintain revision histories and change control logs.
• Ensure all writing activities comply with cGMP and regulatory requirements.
• Participate in process improvement projects to enhance documentation quality and efficiency.
• Prepare Process and Cleaning Validation Protocols and Reports.

Skills

Technical writing

cGMP knowledge

Team collaboration

Education

B.Pharm

M.Pharm

Job description

Job Description:

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 clear, 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

QUALIFICATIONS

Education

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge:

Licenses:

Requirements: