Auditor II, QA (Good Pharmacovigilance Practice exp required)

ROLE OVERVIEW

Auditor II, QA (Good Pharmacovigilance Practice exp required) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Job Responsibilities JOB SUMMARY Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures (SOPs) and work instructions (WIs), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs. JOB RESPONSIBILITIES General Profile Syneos Health Audits: - Plans and conducts assigned 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. - Assists senior QA personnel in hosting or supporting Regulatory Authority Inspections.