Who we are looking forPurposeTo verify and ensure the compliance and the correct application of Good Clinical Practices (GCP) being primarily responsible for the management of all the GCP CAPAs, preparation of the quality metrics, KPIs supporting the compliance inside Global R&D Departments, management of Quality Documents and by execution of first and second party audits. Main ResponsibilitiesManagement of CAPA Plans from GCP auditsManagement of the requests for the collection of quality metrics, KPIs supporting Global R&D DepartmentsManagement of Trackwise, Suppliers and Audit workflowsSupport the management of external consultants supporting the Auditing & Supplier Qualification Unit.Finalization of Quality Documents supporting the Auditing & Supplier Qualification Unit.Write/Review SOPs relating to audit and qualification of clinical service providersEnsure training on relevant activities and proceduresEnsure good documentation and traceabilityExecution of GCP first and second party audits Finalization and management of the GCP audit reports Experience RequiredAt least 3 years' experience in Pharmaceutical, Consultancy Companies or Contract Research Organization in the Research & Development environment Quality Assurance with robust knowledge of GCP supporting clinical trials and knowledge of compliance.ISO auditor Certification to be considered an added value EducationScientific degreeLanguagesGood knowledge of EnglishTechnical SkillsKnowledge of GCP requirements and quality systemKnowledge of the pharmaceutical development process supporting clinical trialsKnowledge of training techniqueKnowledge of auditing technique to be considered an added value Soft SkillsPlanning and organizational skillsStrategic thinkingTeam workingQuality orientationCommunication skillsWhat we offerYou would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
