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.
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.