Senior QA Engineer
Sowelo Consulting sp. z o.o. sp. k.
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Senior Auditor, Quality Assurance
ICON plc
full-time
Posted on:
Location: 🇿🇦 South Africa
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Developing and implementing quality assurance strategies and processes to support clinical trial activities.
- Conducting quality assessments and audits to ensure compliance with regulatory standards and guidelines.
- Collaborating with project teams to identify and address quality issues and implement corrective actions as needed.
- Providing guidance and support to staff regarding quality assurance policies, procedures, and best practices.
- Contributing to the development and maintenance of quality management systems and documentation.
- Oversight of incoming site audit work load; supporting project teams and auditors with finding responses, RCA and CAPA development, and ensuring QMS quality.
- Leading CAPA development for any critical issues; partnering with clinical operations to trend external site audit data.
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
- Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry.
- Knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
- Strong analytical and problem-solving skills, with the ability to identify and resolve quality issues effectively.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
- Prior experience with CAPA development and root cause analysis; knowledge of site audit processes is a plus.
