• Senior Audit Manager

    Job Location(s) IN-Mumbai
    Job Number
    Job Category
    Quality Assurance
    Position Type
  • Job Overview

    • Supports the development of robust quality systems in QA
    • Scopes and leads complex audits (e.g., directed, process, systems, office)
    • Leads audit teams in the conduct, reporting and follow up of regional and global QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
    • 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
    • Provides QA support to internal business partners
    • Proactively identifies and leads process improvement activities / SOP creation and revision
    • Able to host client audits and co-host regulatory inspections
    • Leads and/or participates in special projects
    • Represents Audit QA on project teams and other internal forums
    • Trains and mentors junior QA Audit staff / suppolt onboarding of new personnel
    • Responsible for providing subject matter expertize to RCQA and business partners
    • Trains and mentors new and less experienced audit staff
    • Proactively identifies and interprets changes in regulatory environment
    • Prepares overviews of audit findings for presentation to management. Assists in the analyses for trend and signal detection.


    • Thank you University/college degree BA/BS or equivalent (Life sciences preferred)
    • Thorough 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 from the CRO's or a sponsor's perspective


    Minimum 9 years CRO/Pharmaceutical experience and 8 years in a GXP quality role, including at least 6 years in a GCP quality role required


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