GxP Technical Writer

DGXPComplianceLab; Hyderabad; On-site; INR 900,000 - 1,400,000; Full time

Job summary

DGXPComplianceLab is seeking a GxP Technical Writer to author and revise SOPs, work instructions, policies and validation documents. You will collaborate with SMEs to prepare protocols, reports, technology-transfer materials and process documentation, while keeping templates and style guides up to date.

You will interview SMEs to structure complex content, ensure compliance with GMP and ALCOA+ standards, and participate in document reviews to resolve comments, supporting manufacturing and QC

Qualifications

• 4–9 years of technical writing in pharma or GxP.
• Knowledge of GMP documentation and ALCOA+.
• Experience with a document management system (DMS).
• Ability to interview SMEs and structure complex content.

Responsibilities

• Write and revise SOPs, work instructions and policies
• Author validation protocols and reports with SMEs
• Prepare technology-transfer and process documentation
• Run document reviews and resolve comments
• Keep templates and style guides current

Skills

Pharma/GxP writing

GMP docs

ALCOA+

Document management system

Interview SMEs

Job description

GxP Technical Writer

Author clear, inspection-ready SOPs, validation documents and technical reports.

• Write and revise SOPs, work instructions and policies
• Author validation protocols and reports with SMEs
• Prepare technology-transfer and process documentation
• Run document reviews and resolve comments
• Keep templates and style guides current

Required skills

• 4–9 years of technical writing in pharma or GxP
• Knowledge of GMP documentation and ALCOA+
• Experience with a document management system
• Ability to interview SMEs and structure complex content

Preferred skills

• Regulatory writing (CTD modules)
• Visual process mapping (e.g. Visio, Lucidchart)

Project / industry exposure

• Manufacturing, QC and validation documentation