Quality Assurance Auditor | Clinical Research | GCP

Quality Auditor

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:

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:

system (QMS). This includes reviewing quality events, incidents, and complaints to identify

root causes and recommend corrective and preventative actions (CAPAs).

* Documentation and Reporting:

non-conformities, and recommendations for improvement. Present these findings to senior

management and work with various teams to ensure issues are resolved.

* Regulatory Compliance:

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:

(such as GCP), and the importance of a quality-focused approach.

Required Skills and Qualifications:

* Education and Experience:

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

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:

clearly articulate audit findings and work collaboratively with diverse teams and

stakeholders.

Knowledge of Regulations:

relevant clinical trial regulations are a fundamental requirement.

Certifications:

Quality (ASQ), can be advantageous.

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