The candidate will work for the REMI System Project: Create a centralized IT system framework to automatically acquire, analyze, and report global manufacturing data for improved compliance with process and product monitoring.
• Important: We are looking for a senior documentation specialist, experience with GxP documentation following the company’s PMM and using Condor.
• Supports a global project in the manufacturing area in terms of project documentation.
• Creates and reviews GxP documentation according to PMM process and document templates
• Leads document creation together with stakeholders on QA, business and IT side and ensures approval.
• Excellent ability to communicate to others not only what is being done and how, but also why.
• Support IT and Quality while discussing CSV strategy.
• Recognized expert-level knowledge of relevant methodologies, technologies, languages, standards and processes with 8+ years of experience.
• Has CONDOR access and experiences to create approval workflows.
• Has proven experience working with PMM process.
Nice to haves:
A plus is HP ALM knowledge (project will rely on HP ALM for testing and traceability matrix).