Clinical Quality Assurance - Lead

Preferred Skills:

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• Experience in QMS and ISMS in Clinical Research Organizations and/or pharmaceutical companies with previous experience in system audits and/or inspections by certification bodies
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• Experience in Phase 1 to 4 Clinical Trials Europe and India
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• Awareness of EU Guidelines
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• Handling of inspection and sponsors audit
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TECHNICAL / FUNCTIONAL COMPETENCIES:

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• Quality Management System design & implementation
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• Local and international regulations, guidelines, and standards related to clinical trials, including GCP
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• Audit
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• Process Improvement methodologies e.g., Six Sigma, Lean
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• Training
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• Documentation
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Responsibilities:

Quality Management System (QMS) Development:

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• Provide inputs to Quality Director in enhancing the company's Quality Management System (QMS) and controlled documents related to clinical operations.
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• Develop clear, measurable quality objectives aligned with the organization's strategic goals and regulatory requirements in collaboration with Quality Maintenance Manager (QMM).
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Quality Assurance and Audit:

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• Implement regular internal audits (e.g. site audits, trial specific, data management etc.) and inspections to assess the effectiveness of the QMS and identify areas for improvement. •
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• Perform quality checks and audits of Trial Master File (TMF) documents (both paper and electronic) to ensure completeness and accuracy.
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• Execute regular checks to confirm that clinical trial/study-specific plans are being followed at clinical sites and always achieve audit readiness.
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Quality Documentation and Performance Reporting:

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• Develop clinical trial/study-specific quality metrics to provide insights to Quality Director into study team and site performance.
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• Develop periodic reports detailing compliance and non-compliance trends, identifying potential risks, and presenting findings to the Quality Director.
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• Monitor the external vendor/supplier qualifications and assess their performance by conducting audits.
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