Bausch Health

  • Internal Quality Auditor

    Location US-FL-Tampa
    Job ID
    12380
    Category
    Operations
    Pos. Type
    Full Time
  • Overview

    Responsible for the maintain Quality Assurance Internal audit program (including tracking of internal Audit CAPAs, etc.) and compliance to regulations and established standards. This includes maintaining internal audit schedule and CAPAs generated from internal audit.

    Responsibilities

    1.         Coordination of preparation and execution of Internal Audit. Ensure completion of Tampa Internal (Self Inspection) Audits per audit schedule and ensures that audits are completed within timeline.
    2.         Works with CAPA owners to ensure adequate CAPA plans and ensure implementation according to CAPA due dates. Performs CAPA verification / effectiveness reviews.
    3.         Assist on activities related to any market actions, field alert reports and other regulatory actions.
    5.         Maintain inspections/audits CAPAs (root cause analysis, corrections, corrective action, preventive action and effectiveness checks).
    6.         Supports other audit related activities such as regulatory inspections, customer audits, providing internal audit class training, reporting of monthly metrics data, etc.

    7.         Any other duties as assigned.

    Qualifications

    • BS in Physical Science, Engineering or related field.
    • Special Skills: Compliance and regulatory knowledge; Auditing experience, and thorough knowledge of compounding, filling and packaging processes within the pharmaceutical industry.
    • Ability to work independently.
    • Ability to communicate and work well with others.
    • Knowledge of GxP compliance requirements.
    • Must be able to read, write and speak English and possess basic math skills.

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