Beschreibung
Project Background:
Our client Hoffmann La Roche, worldwide Leader in the Pharma industry, is looking for a CSV Specialist
The candidate will work for a central System Project aiming at creating a centralized system framework to automatically acquire, analyze, and report global manufacturing data for improved compliance with process and product monitoring.
The focus is on a Senior documentation specialist with profound Roche experience with GxP documentation following Roche PMM and using Condor
Key responsibilities
- 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.
Your profile:
- Recognized expert-level knowledge of relevant methodologies, technologies, languages, standards and processes with 8+ years of experience.
- You bring experience with the Roche internal CONDOR access and also experiences to create approval workflows.
- Aware of the Roche PMM process.
Languages:
- Excellent written and verbal communication skills (English)