Job Summary
Technical Writer, SDLC Documentation (GxP Systems)
- 4-7 years of technical writing experience, with minimum 3 years specifically in GxP/regulated life sciences environments.
- Demonstrated experience authoring the full SDLC document set: URS, FRS, Design Specs, Test documentation, Release Notes, SOPs.
- Strong understanding of Computer System Validation (CSV) documentation requirements and how documentation maps to validation deliverables.
- Experience working within a formal document management/eQMS system with version control and electronic approval workflows.
- Ability to translate technical/system-level detail (from engineers, not always well-documented) into clear, standardized, audit-ready prose.
- Experience working in Agile/Scrum delivery, producing documentation aligned to sprint/release cadences rather than only end-of-project.
- Excellent written English — this is the core competency for the role.
Key Responsibilities
Technical Writer, SDLC Documentation (GxP Systems)
- 4-7 years of technical writing experience,
with minimum 3 years specifically in GxP/regulated life sciences environments.
- Demonstrated experience authoring the full SDLC document set: URS, FRS, Design Specs, Test documentation, Release Notes, SOPs.
- Solid understanding of Computer System Validation (CSV) documentation requirements and how documentation maps to validation deliverables.
- Experience working within a formal document management/eQMS system with version control and electronic approval workflows.
- Ability to translate technical/system-level detail (from engineers, not always well-documented) into clear, standardized, audit-ready prose.
- Experience working in Agile/Scrum delivery, producing documentation aligned to sprint/release cadences rather than only end-of-project.
- Excellent written English — this is the core competency for the role.
Skill Requirements
Must Have Skill
Computer System Validation (CSV),Software Development,Technical Writing
Good to Have Skill
Other Requirements
📌 Technical Lead (India)
🏢 HCLTech
📍 India