136 days ago on randstad.ch

Senior Computer Systems Validation Specialist (Scientific & Manufacturing)

Randstad (Schweiz) AG

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Senior Computer Systems Validation Specialist (Scientific & Manufacturing)

Senior Computer Systems Validation Specialist (Scientific & Manufacturing)in Kaiseraugst

veröffentlicht: Mittwoch, 7. September 2016
Ort Kaiseraugst, Aargau SektorLife SciencesJobtyp Contract Referenznummer7450KontaktPeter Pankaczi, Zürich Professionals ITTelefon058 201 56 60
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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. 


• 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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