Job DescriptionPreferred Skills:
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Experience in QMSand ISMS in Clinical Research Organizations and/or pharmaceutical companies with previous experience in system audits and/or inspections by certification bodies N
Experience in Phase 1 to 4 Clinical Trials Europe and India N
Awareness of EU Guidelines N
Handling of inspection and sponsors audit N
nTECHNICAL / FUNCTIONAL COMPETENCIES:
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Quality Management System design & implementation N
Local and internationalregulations, guidelines, and standards related to clinical trials, including GCP N
Auditn
Process Improvement methodologies e.G., Six Sigma, Lean N
Trainingn
Documentation N
nResponsibilities:
NQuality Management System(QMS) Development:
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Provide inputs toQuality Director in enhancing the company's Quality Management System (QMS) and controlled documents related to clinical operations. N
Develop transparent,
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 regularinternal 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. 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