Covance

  • Auditor II QA&C

    Job Location(s) IN-Bangalore
    Job Number
    2018-23074
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

    The auditor is responsible for conducting internal and external QA audits per Standard Operating Procedures and Master Audit Plan assuring that the audited systems and processes comply with applicable regulations and guidelines and fulfill client and Covance requirements. The position assures that audits assigned are completed on time and within budget, including audit reporting and CAPA follow up and closure

     

    Essential Job Duties:

                                                                    

    • As assigned, schedules, conducts and reports routine QA audits in accordance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
    • Provides suitable recommendations for audit observations; ensures auditees provide appropriate CAPAs and follows them up through closure
    • Participates in complex, directed and/or global QA audits
    • Supports process improvement activities / SOP updates
    • Supports client audits and regulatory inspections
    • Participates in special projects
    • Represents Audit QA on project teams and other internal forums
    • Able to support client audits and regulatory inspections

    Education/Qualifications

    Minimum Required:

    • University/college degree BA/BS (life sciences preferred) or equivalent experience

     

    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 organization

    Experience

    Minimum Required:

    10+ years CRO/Pharmaceutical experience

     

    Preferred:

    5 years in a GXP quality role

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