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
- Ensures documentation, investigation, and tracking of major deviations and potential Serious Breaches in GCP
- 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.
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