
Senior Quality Assurance Professional
2 days ago
Clinical Trial Quality Specialist
This role involves contributing to the development of area-specific guidelines and required tools in Clinical Trials and Quality Management Systems. As a Senior Associate/Principal Associate, you will have experience working with quality systems.
- Develop and review quality system documents.
- Recommend new quality system documents or modifications to existing ones.
- Provide guidance on training for implementation and documentation.
- Offer consultation on the interpretation and practical application of external requirements.
- Responsible for deviations, change controls, and event documentation.
- Consult on root cause analysis and corrective/preventive actions.
- Contribute to risk assessments, audit planning, and quality plans.
- Perform self-inspections and drive improvements.
- Ensure local implementation of quality systems.
Requirements:
- Bachelor's Degree in a science-related field or equivalent work experience.
- Quality systems application experience in a regulated environment.
- Experience in quality control/quality assurance roles.
- Effective project and time management skills.
- Strong interpersonal skills and ability to communicate effectively.
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