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Certified Quality Auditor Requirements
PharmSystem Technologies

Keywords: Certified Quality Auditor, auditor’s responsibilities

 

The Certified Quality Auditor is a professional who understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating, and reporting to determinate a quality system’s adequacy and deficiencies. The Certified Quality Auditor analyzes all elements of a quality system and judges its degree of adherence to the criteria of industrial management and quality evaluation and control systems.

 

Minimum Expectations of a Certified Quality Auditor: 

  1. Must possess the knowledge to effectively conduct different types of objective, ethically based audits using and interpreting applicable quality standards requirements.
  2. Must be able to develop and communicate an audit plan within a defined scope that identifies applicable standards, necessary personnel, required documents and tools, and an audit agenda.
  3. Must be able to effectively execute an audit plan, including the opening meeting, performing the audit and the closing meeting using generally accepted auditing techniques and verifying, documenting, and communicating findings as appropriate for the audit.
  4. Must be able to objectively present verified nonconformances to the audited standard and evaluate the effectiveness of the resultant follow-up corrective action activities in an ethical and timely manner.
  5. Must know and be able to apply basic auditing tools and techniques such as flowcharting, the concept of variation, observation techniques and physical examination techniques. The CQA must also demonstrate a general knowledge of quality control tools, descriptive statistics, and applicable sampling theories.

Eight years of on-the-job experience are required in one or more of the areas of the Certified Quality Auditor Body of Knowledge. A minimum of three years of this experience must be in a decision-making position. Decision-making is defined as the authority to define, execute or control project processes and to be responsible for the outcome. This may include management or supervisory positions (AUD3010).

 

 

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