Senior Validation Specialist
LS Solutions - South San Francisco, CA
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***** Quality CSV SME***** 6+ months ***** South San Francisco, CAJOB DESCRIPTIONQuality CSV SMEJOB DESCRIPTION Our client is a small Biotech research company. They are currently seeking a Quality CSV SME to come on-site 3 days a week in South San Fran. This role is responsible for compliance oversight of computer system validation projects as part of the quality assurance team. This role will share strategic responsibility for the QA CSV function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders.The **Reporting to the Director, QA Computer System Validation (CSV), the Associate Director, CSV is responsible for compliance oversight of computer system validation projects as part of the quality assurance team. This role will share strategic responsibility for the QA CSV function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders.Key *• Implement CSV **** Assist in the execution of GxP computer system validation lifecycle and QA-CSV strategies.• Resource ***** Lead internal and contract resources to ensure effective CSV support for business needs.• Risk ***** Collaborate with functional teams to manage risk assessments and develop mitigation plans.• Documentation ***** Contribute to the review and approval of CSV documentation, including specifications and validation protocols.• Audit ***** Engage in vendor assessments and lead routine and complex audits of internal processes and partners.• Compliance ***** Provide CSV compliance support to QA and other GxP functions, identifying issues and facilitating continuous improvement.• Inspection ***** Prepare for regulatory inspections and assist with responses to findings.• Policy ***** Update and create relevant CSV-related policies, procedures, and templates.• Process ***** Identify opportunities for enhancements based on industry best practices and regulatory requirements.Required Skillset Biopharmaceutical ExperienceCSV ExpertiseTracelink and RIM (Strong Knowledge)GxP Systems ExperienceStrong Communication SkillsThanks,Raja
Created: 2024-10-16