Job Information
IQVIA Quality Specialist in Shanghai, China
Clinical Study QA representative
▪ For the clinical studies assigned, works with the Clinical Research project manager to ensure good clinical practices and relevant regulatory requirements are met
▪ Proactively identify and resolve non-compliance issues within lines of business
▪ Ensure timely CAPA implementation by following up with CAPA owners and scheduling meetings as necessary
▪ Participate to project meeting and ensure timely assistance for all quality related topics
▪ Participate to Vendor’s Quality Assurance Meetings and ensure quality oversight
▪ To contribute to the Service Providers selection and ensure an oversight of quality activities
▪ Support the management of the Quality issue / deviation in collaboration with Service Providers
▪ Implement a quality agreement with Service Provider
▪ Deviations and major breach
o Ensures documentation, investigation, and tracking of major deviations and potential Serious Breaches in GCP
o Organize and coordinate deviation assessment meetings, providing meeting minutes and ensuring communication and escalation as appropriate
Audits and Inspections
▪ Support the audit activities: provide information to audit group for their risk assessment and audit activities, facilitate further investigation of observations (when needed), root cause analysis and definition of CAPA.
▪ Assist in the preparation and conduct of inspection as required.
Training
▪ Support the training sessions with SME, by reviewing training materials or participating in presentations where needed.
▪ Liaise with process owners and trainers to ensure appropriate training material is generated and made available for clinical research activities.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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