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Direct message the job poster from GxPeople Global

Building Life Science teamsferoze.malik@gxpeople.com020 8135 6831

This is a 12 months project and is outside IR35

It can be remote for the right candidate but candidates must be based in the UK.

Technical Author (GXP/GAMP5 Documentation)

We're looking for an experienced Technical Author to join our team. You'll be responsible for

creating, editing, and managing high-quality product development documentation, ensuring it

meets our rigorous standards and regulatory requirements. This role is crucial in translating

complex technical information into clear, concise, and accurate documents for various audiences.

Responsibilities

• Develop and maintain comprehensive technical documentation for our GXP/GAMP5

reports, and user manuals.

• Work closely with subject matter experts, engineers, and quality assurance teams to gather

information and ensure documentation accuracy.

• Translate complex technical concepts into easily understandable language for diverse

• Ensure all documentation adheres to established company templates, styles, and regulatory

guidelines.

• Manage document lifecycles, including version control, reviews, approvals, and archiving.

• Identify and implement improvements to documentation processes and tools.

• Potentially contribute to the automation of documentation generation using specialised

tools.

• Proven experience as a Technical Author in a regulated industry, preferably medical

devices or pharmaceuticals.

• Expert proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint, for

creating and managing complex documents, data, and presentations.

• Strong working knowledge of Atlassian Jira for tracking documentation tasks, issues, and

project progress.

• Extensive experience with Atlassian Confluence for collaborative documentation creation,

knowledge management, and content organisation.

• Demonstrable background in GXP/GAMP5 compliant product development

documentation, understanding the regulatory landscape and requirements.

• Experience with Ketryx or similar platforms for automation the generation of product

development documentation, particularly within medical device development processes.

• Familiarity with other documentation tools and content management systems.

Please get in touch with me if you are looking for a new project.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance and Administrative

• Industries

  Medical Equipment Manufacturing

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