Assistant Manager Technical Writing

Amneal Pharmaceuticals LLC; Ahmedabad District; Vor Ort; INR 1.200.000 - 2.000.000; Vollzeit

Zusammenfassung

Amneal Pharmaceuticals LLC in Ahmedabad is seeking an experienced Technical Documentation Specialist to manage GMP-critical documents, batch records, and standard operating procedures within manufacturing.

The role requires a B.Pharm or B.Pharm with 8–10 years in pharmaceutical documentation, with preference for M.Pharm, and a proven ability to translate complex processes into clear, compliant documentation aligned with FDA/EMA expectations.

Qualifikationen

• B. Pharm is required.
• M. Pharm is preferred.
• 8+ years in pharmaceutical documentation.
• Experience with GMP systems and regulatory standards.

Aufgaben

• Manage and coordinate writing of GMP documents including SOPs, batch records, and work instructions.
• Implement and oversee electronic document management systems.
• Translate complex manufacturing processes into clear, compliant documentation.
• Review and revise existing documents for regulatory alignment.
• Develop documentation schedules and workflows across manufacturing areas.
• Ensure documents meet FDA, EMA, and other authorities.
• Collaborate with QA, Regulatory Affairs, and manufacturing teams.
• Train personnel on writing standards and GMP practices.
• Lead process improvement projects to standardize documentation.

Kenntnisse

Technical writing

GMP documentation

Regulatory compliance

EDMS implementation

Ausbildung

B. Pharm

M. Pharm

Jobbeschreibung

Job Description:

Essential Functions:

• Manage and coordinate technical writing activities for manufacturing SOPs, batch records, work instructions, and other GMP-critical documents
• Implement and manage electronic document management systems to improve document accessibility and control efficiency
• Translate complex manufacturing processes and technical information into clear, accurate, and compliant technical documentation
• Review and revise existing technical documents to ensure accuracy, completeness, and alignment with current regulatory requirements and manufacturing practices
• Develop and implement documentation schedules and workflows to ensure timely creation and revision of technical documents across manufacturing areas
• Ensure all technical documents comply with applicable regulatory requirements including FDA, EMA, and other relevant authorities
• Collaborate with manufacturing, quality assurance, and regulatory affairs teams to ensure technical documents accurately reflect processes and regulatory expectations
• Identify documentation gaps and initiate corrective actions to address them in a timely manner
• Train manufacturing personnel on technical writing standards and GMP documentation best practices
• Lead participation in process improvement projects to develop methods and procedures that enhance documentation quality and standardize technical writing practices.

Qualifications

Education:

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

Experience:

• 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses:

Requirements: