Validation and Remediation of Computer Systems

Vertragsart:
Vor Ort
Start:
04.2014
Dauer:
8 Monate (Verlängerung möglich)
Ort:
Solothurn, Mezzovico, Hägendorf
Eingestellt:
23.04.2014
Land:
flag_no Schweiz
Projekt-ID:
698475

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Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
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Our client from the medical industry asked us for support in the validation and remediation of computer systems for each of the three locations Solothurn / Mezzovico / Hägendorf. They are looking for a CSV Business Analyst

Description:
Work with IT and Computer System Compliance (CSC) partners on remediating computer systems at manufacturing plants. Work with and support the Business Owners with the business deliverables for Computer Systems Validation of GxP including not limited to:
• Requirements Identification and documentation
• System Test Scripting
• System Test Execution
• UAT Test Scripting
• Writing of Work Instructions/Procedures
Work with IT and CSC in planning of validations of GxP systems. Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations.

MUST-Knowledge/Skills/Certificates:
• Higher education (Engineer or similar)
• Background in Computer System Validation
• At least 5 years work experience, familiarity with medical device manufacturing plants
• At least English & German fluent
• Knowledge of national and international regulations and standards like GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11