Preferred Skills: /n /n /n
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

/n /n /n TECHNICAL / FUNCTIONAL COMPETENCIES: /n /n /n
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

/n /n /n Responsibilities: /n /n Quality Management System (QMS) Development: /n /n /n
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 transparent, measurable quality objectives aligned with the organization’s strategic goals and regulatory requirements in collaboration with Quality Maintenance Manager (QMM).





/n /n /n Quality Assurance and Audit: /n /n /n
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.

/n /n /n Quality Documentation and Performance Reporting: /n /n /n
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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📌 Clinical Quality Assurance Lead Jamnagar (India)
🏢 Veeda Lifesciences
📍 India