- 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
- Experience in Phase 1 to 4 Clinical Trials Europe and India
- Awareness of EU Guidelines
- Handling of inspection and sponsors audit
TECHNICAL / FUNCTIONAL COMPETENCIES:
- Quality Management System design & implementation
- Local and international regulations, guidelines, and standards related to clinical trials, including GCP
- Audit
- Process Improvement methodologies e.g., Six Sigma, Lean
- Training
- Documentation
Responsibilities:
Quality Management System (QMS) Development:
- Provide inputs to Quality Director in enhancing the company’s Quality Management System (QMS) and controlled documents related to clinical operations.
- Develop explicit, measurable quality objectives aligned with the organization’s strategic goals and regulatory requirements in collaboration with Quality Maintenance Manager (QMM).
Quality Assurance and Audit:
- 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. •
- Perform quality checks and audits of Trial Master File (TMF) documents (both paper and electronic) to ensure completeness and accuracy.
- Execute regular checks to confirm that clinical trial/study-specific plans are being followed at clinical sites and always achieve audit readiness.
Quality Documentation and Performance Reporting:
- Develop clinical trial/study-specific quality metrics to provide insights to Quality Director into study team and site performance.
- Develop periodic reports detailing compliance and non-compliance trends, identifying potential risks, and presenting findings to the Quality Director.
- Monitor the external vendor/supplier qualifications and assess their performance by conducting audits.