Job Description: General position summary: This role is responsible for managing real time inspection readiness... expertise and project management of inspection readiness, as well as provide support during inspections. This role is recognized...
arrangements are not accepted. GENERAL POSITION SUMMARY: The Inspection Readiness Manager role is responsible for leading real...-time inspection readiness activities supporting Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP...
including execution and implementation of mitigating controls Support audit and inspection readiness activities. Act...Job Description The Senior Manager will lead the day-to-day QA oversight including execution of batch disposition...
§ Performing QC checks on TMFs to ensure completeness and readiness for audit/inspection § Contributes to clinical trial excellence... TMF Quality Check (per SOP) with the CRO ensure the eTMF inspection readiness. § Coordinate the final TMF reconciliation...
Partnering with Development Country Quality and Medical Advisor Pipeline to ensure quality mindset, and Inspection Readiness... Directors, Global Study Managers), and other local study team members (Study Start-up Managers, Site Contract Associate...
about vendor risk that inform audit planning, inspection readiness, and governance strategies employed by quality counterparts... outcomes and real time inspection readiness Provides leadership to implementation of risk-based approaches to quality...
and inspection readiness including assisting in preparation of audit responses for Cell & Gene Audits. Act as a trusted advisor... by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers...
quality and a focus on inspection readiness throughout. Proactively identifies study and program risks and implements... inspection readiness throughout. Excellent understanding of GCP, CFR and ICH Guidelines. Effective team leadership in cross...