Clinical Quality Assurance Specialist, GCP Compliance
2 weeks ago
Celerion is a leading global contract research organization committed to delivering exceptional clinical research through translational medicine. Our team of experts uses innovative research strategies to help get drugs to market faster.
Job OverviewThis is a full-time position based at our Belfast facility, with the option to work from home occasionally. As a Quality Assurance Auditor, you will play a crucial role in ensuring study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits.
Main Responsibilities:- Audit Execution: Conduct thorough audits of study, project, and process reports, records, and data, identifying areas for improvement and reporting findings to operations via QA audit reports.
- Client Interaction: Engage with internal and external clients to discuss QA observations and study-related issues, maintaining effective and professional working relationships within and across departments.
- Process Improvement: Participate in initiatives aimed at enhancing quality, compliance, and efficiency of processes.
- Quality Issue Detection: Identify quality issues and initiate CAPAs, evaluating deviations and investigations.
- Regulatory Support: Assist with Client Audits and/or Regulatory Inspections, ensuring seamless coordination and execution.
- Bachelor's degree in a relevant field (science, IT, business, or similar)
- Minimum 2-5 years of quality/functional operations/clinical experience, preferably in GCP or GMP environments
- Excellent oral and written communication skills
- Ability to manage multiple priorities, adapt to changing environments, and maintain attention to detail
- Proficiency in electronic data management and computerized systems
- Flexibility to travel as needed
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