Computer System Validation Specialist Job at Stark Pharma Solutions Inc, California

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  • Stark Pharma Solutions Inc
  • California

Job Description

Job Title: Computer System Validation Specialist
Location: Redwood City, CA (Onsite)

Experience: 5-10 Years
Duration: 12+ Months Contract

Job Summary

We're seeking a Computer System Validation Specialist with strong hands-on experience in validation activities for Veeva QMS, QDS, and RIMS systems within a pharmaceutical or life sciences environment. This role will focus on User Acceptance Testing (UATs), periodic reviews, test script development, and change controls , ensuring all system updates meet compliance and quality standards before rollout.

The ideal candidate has worked in fast-paced regulated environments, understands GxP validation processes, and can collaborate closely with IT and Quality teams to deliver high-quality validation documentation and support system releases.

Key Responsibilities
  • Develop and execute UATs, test scripts, and periodic reviews for Veeva QMS, QDS, and RIMS systems.

  • Create and manage change controls related to Veeva QDS and system enhancements.

  • Prepare validation summary reports outlining testing outcomes and compliance status before release.

  • Collaborate with the IT CSV and IT Business Relationships teams to align validation activities with ongoing system updates.

  • Support multiple monthly releases and ensure all validation deliverables meet quality and regulatory standards.

  • Participate in final UATs and documentation wrap-up for recent Veeva system implementations.

  • Conduct impact assessments for system updates and contribute to validation planning and risk assessments.

  • Maintain validation documentation in accordance with internal SOPs and regulatory requirements.

  • Communicate validation progress, risks, and results with leadership and key stakeholders.

Required Skills and Experience
  • Proven experience as a CSV Consultant within the pharmaceutical or life sciences industry.

  • Hands-on experience in Veeva system validation specifically QMS, QDS, and RIMS .

  • Strong knowledge of GxP, 21 CFR Part 11, and system validation lifecycle principles.

  • Demonstrated experience in developing:

    • User Acceptance Tests (UATs)

    • Periodic Review Protocols

    • Test Scripts for Veeva Systems

    • Change Controls and Validation Summary Reports

  • Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) and SharePoint for document management.

  • Excellent communication and documentation skills with the ability to present findings to technical and non-technical stakeholders.

Preferred Qualifications
  • Prior experience supporting multiple concurrent validation projects .

  • Understanding of CSV requirements in cloud-based or SaaS environments .

  • Ability to work both independently and collaboratively with cross-functional teams.

Work Environment
  • The consultant will work closely with the IT CSV and Business Relationship teams.

  • Daily interaction with team leads and stakeholders to review progress and align deliverables.

  • The environment supports collaboration and proactive communication between IT and Quality functions.

Job Tags

Contract work, Work at office,

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