Compliance Specialist

As a quality assurance professional, this role ensures all aspects of the quality management system adhere to regulatory standards and established guidelines.

This position is crucial for maintaining clinical trial data integrity and protecting participant safety.

Key Responsibilities

• Conducting Audits : Perform internal audits to verify compliance with GCP guidelines, GDP, company SOPs, and other relevant regulations.
• Quality Management : Evaluate and maintain the quality management system (QMS) by reviewing quality events, incidents, and complaints to identify root causes and recommend corrective actions.
• Documentation and Reporting : Prepare detailed reports that document findings, non-conformities, and recommendations for improvement.
• Regulatory Compliance : Stay up to date with applicable regulations and guidelines from bodies like the FDA and ICH. Ensure these requirements are communicated and implemented across the organization.
• Training : Ensure training compliance of quality assurance procedures, GXP guidelines, and the importance of a quality-focused approach.

Required Skills and Qualifications