Deviation & CAPA Specialist

A “Deviation & CAPA (Corrective and Preventive Action) Specialist” is typically responsible for managing and investigating deviations and non-conformances within a manufacturing or quality control environment.

The main tasks of a Deviation & CAPA Specialist include:

• Investigating and analyzing deviations and non-conformances to determine root cause
• Implementing corrective and preventive actions to prevent recurrence of deviations and non-conformances
• Tracking and monitoring the effectiveness of corrective and preventive actions
• Communicating and coordinating with relevant departments and stakeholders to ensure timely resolution of deviations and non-conformances

Requirements

The requirements for a Deviation & CAPA Specialist may vary depending on the employer and the specific industry, but common qualifications include:

• A bachelor’s degree or higher in a relevant field such as engineering, science, or quality management
• Experience in a manufacturing or quality control environment
• Familiarity with quality management systems such as ISO 9001
• Strong problem-solving and analytical skills
• Excellent communication and interpersonal skills

Career opportunities

Career opportunities for a Deviation & CAPA Specialist may include advancement to management roles within quality or regulatory affairs, or opportunities to move into other areas of the organization such as engineering or research and development.

Other terms for the position

Other names for the “Deviation & CAPA Specialist” could be Quality Control Analyst, Quality Engineer, Quality Assurance Analyst, Compliance Specialist, or even CAPA Coordinator.

Background: What are deviations?

Deviations are instances where actual results or performance deviates from expected or specified results or performance. In a manufacturing or quality control environment, deviations can refer to instances where products, processes, or systems do not meet established standards or requirements. Deviations can be classified as either major or minor, depending on the degree of impact they have on the product, process, or system in question.

Examples of deviations in a manufacturing setting might include:
• A batch of product that does not meet established specifications for size or composition
• A piece of equipment that is not functioning correctly and causing variations in the production process
• A process that is not followed correctly, leading to substandard product
• A system that is not working properly, leading to inaccurate data collection

Deviations are important to identify and address because they can have an impact on the quality and safety of products, as well as the efficiency and effectiveness of processes and systems.

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