Executive Technical Writing

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad, India is seeking a seasoned documentation specialist to prepare and maintain cGMP-compliant technical documents, SOPs, and work instructions. You will collaborate with manufacturing, quality, regulatory, and engineering teams to ensure accuracy and regulatory alignment.

The ideal candidate has a background in pharmacy and 5+ years in pharma document control, with strong attention to detail and change-control practices.

Qualifications

• 5+ years of experience in pharmaceutical document control and technical writing.
• Experience with cGMP and regulatory requirements.
• Ability to collaborate with manufacturing, quality, regulatory, and engineering teams.
• Experience in maintaining document revision histories and change control logs.
• Experience in preparing SOPs, work instructions, and technical reports.

Responsibilities

• Prepare, develop, and maintain technical documents in compliance with cGMP.
• Conduct periodic document audits for compliance and traceability.
• Collaborate with cross-functional teams to gather and translate information.
• Review documents to identify gaps and drive updates.
• Maintain document revision histories and change control logs.
• Support training on documentation standards and cGMP.

Skills

Technical writing

cGMP compliance

Document control

Regulatory documentation

Education

B. Pharm

M. Pharm

Job description

Job Description:

Essential Functions

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.

Education

QUALIFICATIONS

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

Experience

• 5 years or more in 5 - 8 Years