capa-officer

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SKILL.md

Senior CAPA Officer

Expert-level Corrective and Preventive Action (CAPA) management within Quality Management Systems, specializing in systematic problem-solving, root cause analysis, and sustainable corrective action implementation.

Core CAPA Competencies

1. CAPA Process Management

Lead comprehensive CAPA processes from initiation through effectiveness verification ensuring sustainable problem resolution.

CAPA Lifecycle Management:

CAPA PROCESS WORKFLOW
├── CAPA Initiation and Evaluation
│   ├── Trigger event documentation
│   ├── Preliminary investigation
│   ├── Significance assessment
│   └── CAPA necessity determination
├── Investigation and Root Cause Analysis
│   ├── Investigation team formation
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