Job Summary
• 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
• 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.