System Validation Analyst

Our Company

 

At 2,000 employees and growing, and consistently strong financials (NYSE:VEEV), Veeva was named among the top fastest growing public technology companies on Forbesannual Fast Tech 25 list. We build innovative cloud solutions for some of the worlds largest pharmas and biotechs, and we need great people like you to make it happen.

 

Our Culture & People

 

Our core values are Employee Success, Customer Success, and Speed. We are innovators, collaborators, and thought leaders out to create best-in-class solutions that help our customers improve and extend human life. Its genuine, straight-forward, and no fuss.

 

Job Summary

The System Validation Analyst will support a range of operational functions, such as vault provisioning, customer communication and user access management to internal tools. Additionally, this role will also have responsibility supporting ongoing validation activities across multiple product lines, general releases and patches/hot fixes. The System Validation Analyst coordinates with Product Managers to ensure product features are documented in compliance with 21 CFR Part 11 requirements.

 

Responsibilities

Validation

  • Perform risk assessment and classification of new features and hot fixes
  • Coordinate Business Requirement Definition document updates with Product Managers
  • Review of Release Impact Assessment for accuracy and completeness
  • Maintain validation procedure documentation
  • Track CAPAs in collaboration with the Q&C team

 

Operations

  • Management and execution of customer and internal vault provisioning requests
  • User access management for Vault Management Console
  • Pre-release support on vault provisioning and customer access
  • Manage/Address customer support requests assigned to Product Operations queue and Provisioning cases assigned by Finance
  • Weekly communication distribution to targeted customer lists based on applicable hot fixes

 

Requirements

  • Bachelors degree (BA/BS) or equivalent relevant experience
  • 2-3 years of experience in computer system validation, operations, and/or project management role
  • Experience working in a team with similar roles where work is shared/managed via a common queue
  • Ability to work under a deadline driven environment with flexibility to shift priorities as needed
  • Excellent communication skills

 

Nice to Have

  • Knowledge of GxPs and principles of computer validation
  • Hands-on experience with the validation of enterprise applications in the Life Sciences such as EDMS, CTMS, CDMS, AERS, EDC, CRM, and/or Quality Information Systems (e.g., Change Control, CAPA)
  • Knowledge of Vault platform is a plus

 

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.

 


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