Senior CAPA Officer specialist for managing Corrective and Preventive Actions within Quality Management Systems. Provides CAPA process management, root cause analysis, effectiveness verification, and continuous improvement coordination. Use for CAPA investigations, corrective action planning, preventive action implementation, and CAPA system optimization.
8.1
Rating
0
Installs
Business & Productivity
Category
Excellent domain-specific skill for CAPA management in regulated industries. The description clearly articulates capabilities for corrective/preventive action management, root cause analysis, and QMS integration. Task knowledge is comprehensive with detailed workflows, methodologies (5 Why, Fishbone, FMEA), and cross-functional integration points. Structure is logical with clear competency areas and well-organized resources. Novelty is good - while a CLI agent could theoretically handle CAPA processes, the specialized domain knowledge, regulatory compliance requirements (ISO 13485, FDA 21 CFR 820), systematic frameworks, and interconnected QMS processes make this skill valuable for token efficiency and domain expertise. Minor improvement opportunities: could benefit from more concrete decision trees or scoring matrices for RCA method selection. Overall, a well-constructed skill that would meaningfully assist quality professionals in complex, regulated environments.
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