Remote Cloud System Validation Analyst in San Francisco

Job Summary

A global professional services firm has a current position open for a Remote Cloud System Validation Analyst in San Francisco.

Core Responsibilities Include:

• Advise clients on assigning proper risk to computer systems
• Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA 21 CFR Part 11 requirements
• Develop test / validation scripts based on software design and configuration

Required Skills:

• University certificate or degree with a minimum of 5 years of related industry experience
• OR BS in Technology & 2-3 years of experience
• Minimum of 1-2 years as a validation lead
• Minimum 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validation
• Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance
• Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Smartsheets and Salesforce