Job Description Preferred Skills:
n n 6 to 7 years' 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
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 n TECHNICAL / FUNCTIONAL COMPETENCIES:
n n Quality Management System design & implementation
n Local and international regulations, guidelines, and standards related to clinical trials, including GCP
n Audit
n Process Improvement methodologies e.g., Six Sigma, Lean
n Training
n Documentation
n n Responsibilities:
n Quality Management System (QMS) Development:
n n 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 n Quality Assurance and Audit:
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. •
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 n Quality Documentation and Performance Reporting:
n n 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 qualifications and assess their performance by conducting audits.
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