• Senior Auditor II

    Job Location(s) CN-Beijing | TW-Taipei City | HK
    Job Number
    Job Category
    Quality Assurance
    Position Type
  • Job Overview

    • Leads the conduct, reporting and follow up of regional and local QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
    • Conducts complex, directed, and/or time sensitive QA audits
    • Participates in global QA audits
    • Provides suitable recommendations for audit observations; ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate
    • Able to support client audits and regulatory inspections
    • Leads and/or participates in special projects
    • Represents Audit QA on project teams and other internal forums
    • Trains and mentors junior staff


    • University/college degree BA/BS (life science preferred)
    • Knowledge, understanding, and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs
    • Knowledge of the drug development process from the perspective of a contract research organizationExperience


    • 5 years CRO/Pharmaceutical experience, with global company experiences are preferred
    • 4 years in a GXP quality role, including at least 2 years in a GCP quality audit role required


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