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🥝 Technical Writer Regulated Digital & Quality Systems

NR Consulting - India | hyderabad, India | Posted June 05, 2026

Job Description

Title: Technical Writer – Regulated Digital & Quality Systems
Location: Hyderabad
Exp: 10 years

Job Description:

Core Responsibilities:
Documentation Development & Ownership
Develop, revise, and maintain controlled documentation including:
• Standard Operating Procedures (SOPs)
• Work Instructions (WI)
• Functional Specifications (FS)
• Design Specifications (DS)
• Validation Documentation (IQ/OQ/PQ)
• User Guides and System Documentation
• Change Control and Process Documentation
• Training and Operational Support Materials
Own documentation quality from draft creation through approval and release.

Regulatory & Compliance Alignment
Ensure all documentation adheres to:
• GxP / GMP standards
• FDA 21 CFR Part 11 requirements
• Data Integrity principles (ALCOA+)
• Internal quality ma...

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