Quality Specialist In Clinical Safety
hace 1 mes
Job Summary
We are seeking a Quality Specialist In Clinical Safety to support the development and implementation of quality systems strategy and activities to support International Business Unit (IBU) goals and objectives for assigned countries or regions. The ideal candidate will have a strong understanding of quality systems and be able to integrate quality requirements into business processes.
Key Responsibilities
- Implement and manage quality systems
- Contribute to the development and review of country/region specific quality system documents
- Approve regional and/or local required tools, resources, forms, templates
- Assist in interpreting relevant regulations and guidelines
- Recommend new procedures or changes to existing procedures
- Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed
- Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process
- Support the business on the application and facilitation of quality systems
- Support activities and processes related to external party management
- Perform quality self-assessments, as needed
- Provide Quality Oversight for business area(s)
- Monitors and provide quality oversight for compliance to Safety & Efficacy Quality System (SEQS)
- Communicates and escalates compliance issues to management locally and globally, as appropriate
- Provide consultation on the interpretation and practical application of external requirements, standards, and procedures
- Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary
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