CLINICAL QUALITY ASSURANCE AUDITOR
Scientific Search International Group
Barcelona, Spain
hace 4 días
source : Experteer

Scientific Search InternationalScientific Search International es una consultora íntegramente formada por científicos con formación y experiencia en el ámbito de los recursos humanos, que dirige sus servicios a los principales sectores relacionados con la ciencia y la tecnología.

Job descriptionSCIENTIFIC SEARCH INTERNATIONAL, a specialized outsourced services provider to the healthcare arena, is searching for a multinational pharmaceutical company headquartered in Barcelona aCLINICAL QUALITY ASSURANCE AUDITORWithin 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).

RequirementsDegree in life sciences (e.g. Biology, Pharmacy, Chemistry).Fluent level of English both oral and written is a must.

4 years in the pharma, biotechnology or medical device industries.Solid experience in GCP QA.The successful candidate will be a team player with integrity, a commitment to quality, and the ability to think critically and creatively.

Candidate must possess strong verbal and written communication skills.Candidate must be able to prioritize, be organized and detail-oriented and demonstrate strong analytical skills.

Up to 15% travel may be required.Location : Barcelona (Spain)Contract : Contract for Works and ServicesWorking day : Full timeSector : Pharmaceutical and biopharmaceuticalVacancies : 1Discipline : Quality

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