What are the responsibilities and job description for the CAPA Specialist position at Katalyst Healthcares & Life Sciences?
Job Description:
The CAPA Specialist is responsible for overseeing and supporting the development, implementation, and management of corrective and preventive action (CAPA) processes in compliance with FDA regulations, and other relevant industry guidelines. The individual will work cross-functionally with various departments to ensure that quality issues are investigated, root causes are identified, and effective corrective and preventive actions are implemented to ensure ongoing product quality and regulatory compliance.
Responsibilities:
The CAPA Specialist is responsible for overseeing and supporting the development, implementation, and management of corrective and preventive action (CAPA) processes in compliance with FDA regulations, and other relevant industry guidelines. The individual will work cross-functionally with various departments to ensure that quality issues are investigated, root causes are identified, and effective corrective and preventive actions are implemented to ensure ongoing product quality and regulatory compliance.
Responsibilities:
- Manage the end-to-end CAPA process, including root cause analysis, corrective actions, and preventive measures.
- Ensure that all CAPA activities comply with FDA regulations, Good Manufacturing Practices (GMP), and relevant ISO standards, specifically related to medical devices (e.g., 21 CFR Part 820) and pharmaceuticals.
- Investigate non-conformities, deviations, and complaints to determine root causes.
- Work proactively with teams to identify potential risks and implement preventive actions to reduce the occurrence of non-conformances.
- Work with cross-functional teams to implement effective corrective actions.
- Analyze historical data, adverse events, and complaint trends to identify areas for improvement in the design, manufacturing, or post-market monitoring of medical products.
- Maintain accurate and up-to-date CAPA records and reports.
- Prepare and present CAPA metrics, trends, and effectiveness reports to senior management. Analyze trends in CAPA data to identify potential systemic issues that require attention.
- Conduct training on CAPA procedures and best practices.
- Support internal and external audits by providing CAPA records and evidence of compliance.
- Bachelor's degree in engineering, Quality, or Life Sciences related areas.
- 4-6 years of experience in CAPA management, quality assurance, or regulatory compliance.
- Strong knowledge of root cause analysis tools (e.g., 5-Whys, Fishbone Diagram, FMEA).
- Strong understanding of medical device regulations (21 CFR Part 820), pharmaceuticals (21 CFR Part 210/211), and ISO 13485.
- Familiarity with regulatory compliance tools, such as risk management software and CAPA management systems.
