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Quality Assurance Specialist
vor 2 Monaten
Overview of the Role
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.
Main Responsibilities:
- CAPA Process Management: Manage the CAPA process of multiple CAPAs from initiation to closure, ensuring timely and effective resolution of issues with minimal oversight and direct others.
- Investigation and Root Cause Analysis: Conduct thorough investigations of complex non-conformances and deviations to identify root causes and develop strategy with appropriate business acumen.
- Corrective and Preventive Actions: Develop and implement corrective and preventive action plans to address identified issues.
- Effectiveness Monitoring: Monitor the effectiveness of CAPA actions and make necessary adjustments.
- Collaboration: Collaborate with cross-functional teams and multiple sites to ensure CAPA actions are integrated into relevant processes.
- Documentation: Maintain excellent accurate and detailed documentation of CAPA activities.
- Reporting: Prepare and present CAPA reports to management and regulatory bodies as required.
Qualifications:
- A Master's degree in a related field (e.g., Quality Assurance, Engineering, Life Sciences).
- A minimum of 9 years of experience in CAPA management or a related quality assurance role.
- A strong understanding of regulatory requirements (e.g., FDA, ISO) and quality management systems.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal skills.
- The ability to work independently and as part of a team.
- Proficiency in using quality management software and tools.
- Fluency in English and German is required.
Benefits:
- A competitive salary of CHF 110,000 per year in Zurich, Switzerland.
- Access to career development opportunities within an international company.
- A dynamic and highly educated team environment.
- A multinational environment fostering talent development.
- Competitive compensations and benefits.
- A workplace in the heart of Zurich.
About Abbott:
We are a global healthcare leader dedicated to helping people live more fulfilling lives through innovative medical products, diagnostic tools, and nutritional products. Our employees are passionate about making a difference in people's lives and strive to deliver exceptional results in a fast-paced environment.
