Quality Assurance Ne

Quality Assurance
Ne
Liguria, Ne

Aptuit, an Evotec company, is a worldwide Contract Research Organization, collaborating with all the major Pharma and Biotech companies in support of various drug discovery and development projects including Phase I clinical trials. To efficiently support ongoing activities and needs, we are looking for a highly motivated Quality Assurance Specialist with knowledge and experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Computer System Validation (CSV) to work in GLP/GCP Quality Assurance team. The role of the GLP/GCP Quality Assurance team is to ensure that preclinical and clinical studies are compliant with the applicable governance and regulations. Responsibilities:

Review protocols, data and reportsPerform internal inspectionsReview and approve Standard Operating ProceduresAssist with the preparation of client audits and/or regulatory inspectionsSupport the supplier audit programSupport CSV activities on GxP systemsCollect and trendquality KPIInteract with other departments to discuss QA observationsAttend cross functional meeting as a QA representativeParticipate in assigned projectsAssist or perform other job duties as assigned by Quality Assurance ManagementRequirements: