Job DescriptionPreferred 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 bodiesn
- Experience in Phase 1 to 4 Clinical Trials Europe and Indian
- Awareness of EU Guidelinesn
- Handling of inspection and sponsors auditn
nTECHNICAL / FUNCTIONAL COMPETENCIES:
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- Quality Management System design & implementationn
- Local and international regulations, guidelines, and standards related to clinical trials, including GCPn
- Auditn
- Process Improvement methodologies e.g., Six Sigma, Leann
- Trainingn
- Documentationn
nResponsibilities:
nQuality 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.n
- Develop explicit, measurable quality objectives aligned with the organization's strategic goals and regulatory requirements in collaboration with Quality Maintenance Manager (QMM).n
nQuality 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. •n
- Perform quality checks and audits of Trial Master File (TMF) documents (both paper and electronic) to ensure completeness and accuracy.n
- Execute regular checks to confirm that clinical trial/study-specific plans are being followed at clinical sites and always achieve audit readiness.n
nQuality 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.n
- Develop periodic reports detailing compliance and non-compliance trends, identifying potential risks, and presenting findings to the Quality Director.n
- Monitor the external vendor/supplier