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Senior GCP Auditor
3 weeks ago
My client is a leading company dedicated to ensuring the highest standards of quality and compliance in clinical research. We are committed to advancing health through innovative solutions and maintaining the integrity of our processes and products. We are currently seeking an experienced and detail-oriented GCP Auditor to join our team.
Job Summary: As a GCP Auditor at you will be responsible for planning, conducting, and reporting on audits to ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and company policies. Your role will involve auditing clinical trials, vendors, and internal processes to ensure that our clinical research activities are conducted with the highest level of quality and integrity.
Key Responsibilities:
- Plan, schedule, and conduct GCP audits of clinical trials, sites, vendors, and internal processes.
- Develop audit plans, checklists, and reports.
- Identify and document audit findings, non-compliance issues, and areas for improvement.
- Provide clear, concise, and actionable audit reports to relevant stakeholders.
- Follow up on audit findings to ensure timely and effective resolution.
- Stay current with GCP regulations, guidelines, and industry best practices.
- Provide GCP training and guidance to internal teams and external partners.
- Assist in the development and maintenance of the company's quality management system.
- Support regulatory inspections and contribute to continuous improvement initiatives.
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