Senior Quality Assurance Professional

A Quality Compliance Specialist ensures all aspects of the Quality Management System adhere to regulatory standards and established quality guidelines. This role is crucial for maintaining clinical trial data integrity and protecting participant safety.

Key Responsibilities :

• Conducting / Host Audits : Perform internal and external audits verifying compliance with GCP, GDP, SOPs, and other relevant regulations. Write up an audit report and track findings.
• Quality Management : Evaluate and maintain the company's QMS. Review quality events, incidents, and complaints to identify root causes and recommend corrective actions.
• Documentation and Reporting : Prepare detailed audit reports documenting findings, non-conformities, and recommendations. Present findings to senior management and work with teams to resolve issues.
• Regulatory Compliance : Stay updated on applicable regulations from bodies like FDA and ICH. Ensure these requirements are communicated and implemented across the organization.
• Training : Ensure training compliance of quality assurance procedures, GXP guidelines, and a quality-focused approach.

Required Skills and Qualifications :

We offer a competitive salary package, opportunities for growth and development, and a collaborative work environment.