Job description and tasks:
- Streamline and update all our documentation, currently in version 1.0, to elevate the standards and reflect the latest software version
- Working in GMP environment and required do strictly adhere to proper quality and compliance standards within QC (Quality Control)
- Working with a GMP IT software solution within QC (Quality Control)
- Writing documentation such as: SOPs, User guides, Training material, Continency plan
- Provide a holistic perspective to our documents and create a functional document structure
- Handle documentation updates associated with software releases, including the review flow
- Update documents based on requirements from: end-users, ambassadors, developers, data scientists, SME (QC)
- Regular input gathering from wide variety of stakeholders: QC stakeholders, IT stakeholders, QA stakeholders
- Set up a process for an easy documentation update for future
- Get trained as an editor and take charge of DCCs (Document Change Control)
- Able to work with high-level of detailed information, but also able to zoom-out and provide the big picture overview
Skills:
- Skilled in writing documents (SOPs, user guides, manuals, training materials)
- Understanding of GMP and adherence to GMP, quality and compliance standards
- Able to learn new subjects (IT software usage for Quality Control processes within GMP)
- Detailed oriented, but also able to provide perspective
- Highly structured
- Able to ask challenging questions to meet the required quality standards
- Inquisitive and curious to find answers
- Problem solving mindset
- Able to work efficiently in high-paced environment
Start-date: 1/11-2024
End-date: 31/01-2025 - extension likely
Location: Gentofte Denmark
Requirements
Required skills
Documentation
GMP
Quality Control
Languages
English