Clinical QA Auditor - Senior Clinical QA Auditor

December 6

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AIXIAL GROUP

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Biometrics and Clinical Research • Contract Research Organisation • biostatistics • data-management • E-CRF

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• Ensures that the Clinical Quality Assurance System meets GCP expectations and includes continuous improvement. • Participates in annual audit program development and implements internal quality control activities. • Manages non-conformities and verifies actions taken. • Plans and conducts internal and external audits. • Manages preparation for audits and ensures compliance with regulatory requirements. • Independently conducts various audits including Clinical Investigator Sites and maintains audit records. • Leads CAPA processes and vendor assessments. • Participates in training material production and employee training.

Requirements

• Minimum of 8-10 years of experience in clinical quality assurance. • Auditor certification or relevant experience to demonstrate the capacity to act as an auditor with prior GCP/GCLP/GVP auditing. • Extensive experience conducting clinical audits and a deep understanding of GCP guidelines and regulatory requirements (FDA, EMA, ICH). • GCLP/GVP Knowledge. • To degree level in a Life Sciences or related discipline or appropriate experience. • Previous experience of Clinical Quality Assurance in the Pharmaceutical and/or CRO sectors. • Excellent analytical, problem-solving, and decision-making skills. • Knowledge of risk-based monitoring approaches. • Excellent communication and interpersonal skills, with the ability to interact effectively with all levels of the organization and external stakeholders. • This position may require occasional travel to clinical sites, vendor locations, and regulatory meetings. • Good knowledge of Microsoft Office 365 and use of SharePoint. • eQMS, LMS knowledge is a plus. • Fluent English is required.