Sr Auditor, QA - CSV (Computer System Validation)Sr Auditor, QA - CSV (Computer System Validation)ResponsibilitiesPlans and conducts assigned audits.Performs auditing of vendor's CSV (Computer System Validation).Performs For Cause audits.Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.Reviews responses to audit findings for appropriateness and completeness.Closes assigned audits. Customer Audits/Inspections.Prepares for and hosts or supports customer audits.Prepares for and hosts or supports Regulatory Authority Inspections. OtherServes as Lead Auditor on team-based Syneos Health audits.Serves as a trainer and mentor to less experienced QA auditors. SupervisionRequires minimal instructions on day-to-day work and new assignments. Other tasksMay write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs).Performs other work-related duties as assigned.Moderate travel may be required (up to 50%).QualificationsRequires a Bachelor’s degree in the science/health care field or equivalent with extensive experience in GxP quality assurance auditing.GCP experienceComputer System Validation experienceVendor Audit experienceProcess Audit experienceExcellent Knowledge of GxP regulatory requirements.Knowledge of Medical and technical terminology related to the audit types to be conducted.Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency).Able to handle multiple tasks to meet timelines in dynamic environment.Strong organizational, presentation and interpersonal skills.Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.Ability to negotiate, problem solve and provide constructive feedback.Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.Get to know Syneos Health: Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
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