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.

其他信息

行业要求：全部行业