Table III

Knowledge and Skills List for the Pharmaceutical Quality Professional

  1. Business Knowledge and Understanding

  2. Customers - internal and external

  3. Leadership and Management

    • • Change Management

  4. Manufacturing

  5. Process and System—Design, Optimization, Assessment, and Management

  6. Risk Management

  7. Tools - root cause analysis, statistical, etc.

  8. Validation

  9. Laboratory and Instrumentation

  10. Documentation

  11. Audits/Assessments/Inspections

  12. Suppliers and Third Party Manufactures