(Immediate Start) Quality Auditor

A Quality Auditor is responsible for ensuring that all aspects of Beaconcure Quality Management System adhere to regulatory standards and established quality guidelines. This role is crucial for maintaining the integrity of clinical trial data and protecting the safety of participants.

Key Responsibilities

• Conducting / Host Audits : Perform internal and host external audits. These audits verify compliance with Good Clinical Practice (GCP) guidelines, Good Documentation Practices (GDP), company standard operating procedures (SOPs), and other relevant regulations. Write up an audit report and track findings.
• Quality Management : Evaluate and help maintain the company's quality management system (QMS). This includes reviewing quality events, incidents, and complaints to identify root causes and recommend corrective and preventative actions (CAPAs).
• Documentation and Reporting : Prepare detailed audit reports that document findings, non-conformities, and recommendations for improvement. Present these findings to senior management and work with various teams to ensure issues are resolved.
• Regulatory Compliance : Stay up to date with all applicable regulations and guidelines from bodies like the FDA and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Ensure that these regulatory requirements are communicated and implemented across the organization.
• Training : Ensure training compliance of quality assurance procedures, GXP guidelines (such as GCP), and the importance of a quality-focused approach.

Required Skills and Qualifications

Annex 11, GDPR, or GAMP 5.