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Computer System Validation/Quality Lead

San Francisco, CA, US • Posted 10 hours ago • Updated 10 hours ago

Contract W2

12 Months

No Travel Required

Able to Sponsor

On-site

$65 - $70/hr

Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

Quality Lead
Veeva Vault
CSV/CSA

Summary

Provide QA oversight for computer system validation activities across Veeva Vault, LIMS, ERP, Clinical Systems, and other GxP-regulated applications.
Review and approve validation lifecycle documents including Validation Plans, URS, FRS, Configuration Specifications, Risk Assessments, Test Plans, IQ/OQ/PQ protocols, UAT scripts, RTM, and Validation Summary Reports.
Ensure validation deliverables are complete, accurate, traceable, and aligned with approved procedures, regulatory expectations, and business requirements.
Review system risk assessments to confirm appropriate validation scope, testing strategy, criticality assessment, and risk-based approach.
Assess 21 CFR Part 11, EU Annex 11, audit trail, electronic signature, security, access control, and data integrity requirements for GxP computerized systems.
Review and approve test scripts, test evidence, screenshots, actual results, deviations, defects, and objective evidence for compliance and completeness.
Verify traceability between requirements, configuration, testing, defects, deviations, and validation summary documentation.
Provide quality review of change controls related to system configuration changes, enhancements, patches, upgrades, releases, integrations, and data migrations.
Ensure validation impact assessments are properly documented for system changes, incidents, deviations, CAPAs, and release activities.
Review deviation investigations, defect resolutions, root cause analysis, impact assessments, corrective actions, and validation remediation plans.
Provide QA oversight for Veeva Vault modules such as QualityDocs, QMS, RIM, eTMF, CTMS, Clinical Vault, and related workflow/document control processes.
Review LIMS validation documentation supporting sample management, testing workflows, specifications, stability, microbiology, environmental monitoring, QC testing, and instrument interfaces.
Provide quality oversight for ERP validation activities involving SAP, Oracle, or similar platforms supporting procurement, inventory, manufacturing, quality, finance, master data, and supply chain processes.
Review clinical system validation documentation for CTMS, eTMF, EDC, IRT, safety, regulatory, and clinical document management systems.
Ensure data migration validation deliverables include proper data mapping, reconciliation, transformation rules, sampling rationale, exception handling, and final migration approval.
Review system periodic review reports, user access review evidence, audit trail review procedures, backup/restore evidence, disaster recovery testing, and system retirement documentation.
Support audit and inspection readiness by ensuring validation packages are complete, organized, approved, and available for regulatory or client review.
Participate in internal audits, supplier audits, client audits, and regulatory inspections by providing validation documentation support and responding to QA-related observations.
Review SOPs, work instructions, training materials, system administration procedures, and validation templates for compliance with CSV/CSA and quality requirements.
Provide guidance to validation analysts, IT teams, business testers, and system owners on documentation quality, test evidence expectations, deviation handling, and QA approval standards.
Ensure validation activities follow approved SDLC, CSV, CSA, GAMP 5, and company quality procedures.
Identify documentation gaps, compliance risks, and process improvement opportunities within validation packages and quality review workflows.
Support release readiness reviews by confirming that validation deliverables, change controls, test execution, defects, deviations, and approvals are completed before production deployment.
Ensure computerized systems remain in a validated state throughout implementation, operation, maintenance, upgrade, and retirement phases.

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Dice Id: 91173678
Position Id: 9014608
Posted 10 hours ago

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Suresh Estamsetty

Recruiter @ Algo Soft Solutions LLC

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PHARMACEUTICAL EXPERIENCE MANDATORY Validation Engineer (Data Lake) Responsibilities: Qualification Strategy & Validation Leadership Lead qualification activities for an enterprise cloud-based Data Lake platform using modern, risk-based CSA methodologies. Assess the current architecture, existing validation deliverables, and identify opportunities to simplify and modernize qualification activities while maintaining compliance. Develop and implement a scalable qualification model supporting fu

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