senior computer systems validation specialist (scientific & manufacturing) in Kaiseraugst

kaiseraugst, argovie
life sciences
type d'emploi
numéro de référence
peter pankaczi, zürich professionals it
058 201 56 60
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description du poste

    Project background
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.   General information: 
• 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.    Requirements:
• 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). 
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