Quality Auditor

Quality Auditor

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

● Education and Experience: A bachelor's degree in a relevant field (e.g., life sciences, or information technology) or equivalent audit experience. The candidate should possess working knowledge of US FDA Good Clinical Practices (GCP), Internal Conference of Harmonization (ICH), Electronic Records; Electronic Signatures (21 CFR part 11) and EU

Annex 11, GDPR, or GAMP 5.

● Analytical Skills: Strong analytical and problem-solving abilities are vital for identifying discrepancies, evaluating data, and drawing logical conclusions from audit findings.

● Attention to Detail: The role demands a meticulous and detail-oriented approach to reviewing documents, data, and processes.

● Communication: Excellent written and verbal communication skills are necessary to clearly articulate audit findings and work collaboratively with diverse teams and stakeholders.

● Knowledge of Regulations: A thorough understanding of GCP, ICH guidelines, and other relevant clinical trial regulations is a fundamental requirement.

● Certifications: Certifications from professional bodies, such as the American Society for Quality (ASQ), can be advantageous.