Quality GCP Auditor
- Relocate to Madrid? General Responsibility The Clinical Quality Auditor ensures the validation and compliance of eClinical systems, including Interactive Response Technology (IRT), Clinical Trial Management Systems (CTMS), Case Report Forms (CRF), Trial Master Files (TMF), Clinical Outcome Assessments (COA), and electronic Patient-Reported Outcomes (ePRO). This role involves cross-functional collaboration to uphold quality and regulatory compliance standards. Additionally, the specialist will support the Global Quality Unit in developing, implementing, and maintaining the companies Clinical Quality System, ensuring compliance with GCP, GLP/GMP guidelines, EMA and FDA/CFR regulations, and other applicable standards. Establish, implement, and maintain the Integral/Corporate Clinical Quality Assurance System.
Support the development and maintenance of Quality Assurance Systems across business units and affiliated units within the company group. Develop and implement quality assurance processes and validation documentation, including plans, protocols, reports, and SOPs. Support the selection and implementation of new Clinical systems and maintain a Global Clinical vendor/service provider database. Provide training and support on CSV processes and regulatory requirements. Bachelor's degree in Life Sciences (e.g., A Master's degree is a plus. Fluent in English; additional languages are a plus. Mid-Senior level Full-time Research, Quality Assurance, and Accounting/Auditing
📌 QA Analyst Senior (España)
🏢 Discover International
📍 España
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