Senior Quality Assurance Specialist
vor 2 Wochen
The Staff CAPA Specialist will be responsible for managing the Corrective and Preventive Action (CAPA) process to ensure compliance with regulatory requirements and internal quality standards. This role involves investigating non-conformances, identifying root causes, and implementing effective corrective and preventive actions.
Key Responsibilities- Manage the CAPA process of multiple CAPAs from initiation to closure, ensuring timely and effective resolution of issues with minimal oversight and direct others.
- Conduct thorough investigations of complex non-conformances and deviations to identify root causes and develop strategy with appropriate business acumen.
- Develop and implement corrective and preventive action plans to address identified issues.
- Monitor the effectiveness of CAPA actions and make necessary adjustments.
- Collaborate with cross-functional teams and multiple sites to ensure CAPA actions are integrated into relevant processes.
- Maintain excellent accurate and detailed documentation of CAPA activities.
- Prepare and present CAPA reports to management and regulatory bodies as required.
- Stay updated on industry regulations and best practices related to CAPA.
- Master's degree in a related field (e.g., Quality Assurance, Engineering, Life Sciences).
- Minimum of 9 years of experience in CAPA management or a related quality assurance role.
- Strong understanding of regulatory requirements (e.g., FDA, ISO) and quality management systems.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficiency in using quality management software and tools.
- Fluency in English and German are required.
- Certification in Quality Management (e.g., ASQ CQE, CQA).
- Experience in (specific industry, e.g., medical devices, pharmaceuticals).
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