SCIENTIFIC SEARCH INTERNATIONAL , a specialized outsourced services provider to the healthcare arena, is searching for a multinational pharmaceutical company headquartered in Barcelona a
CLINICAL QUALITY ASSURANCE AUDITOR
Within the R&D QA Unit, will participate in Clinical Study Teams and CRO selection together with the Clinical Operations department, prepare audit plans for individual audits and audit / risk mitigation plans for larger projects and programs, adopt a risk-based approach in the identification of audit candidates and mitigation strategies related to identified and potential compliance issues, complete and / or oversee (when outsourced to a third party) audit plans / programmes, lead and / or oversee and / or assist with audit activities, conduct qualification / re-qualification audits of clinical trial CROs / vendors.
The suitable candidate will also clearly communicate and report (verbally and in writing) audit outcomes and escalate significant compliance concerns.
Assist the organization in preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections and partner audits.
Evaluate internal compliance with company procedures, policies, programs, initiatives, GCP, and applicable regulations. Prepare training materials and conduct training related to relevant QA topics (GCP).