15 ott - Brindisi
ClinOpsHub
ph3Course Assistant (“Missione CRA” Training Program) /h3 h3Job details /h3 pWork location: Mesagne (BR), hybrid or full-remote. /p pSchedule: Full-time. /p pContract: CCNL Commercio (starting RAL €35k). The gross annual salary (RAL) will be commensurate with the experience of the selected candidate. /p pAbout us /p pClinOpsHub S.r.l. was founded in 2014 by Stefano Lagravinese and, after years of providing services to various clients in the field of Clinical Research, in 2019 it was registered as a Contract Research Organization (CRO) on the AIFA website, in compliance with the requirements set out by Ministerial Decree (CRO Decree). /p pClinOpsHub S.r.l. provides support services to Pharmaceutical Companies, Trial Sites, Laboratories and other CROs at national and international level, ensuring high quality standards thanks to a well-trained team of young professionals. /p pIn view of the imminent increase in projects in the area of quality assurance for clinical trials, we plan to strengthen the Quality Assurance Department.
We are therefore looking for a resource to support ClinOpsHub’s Quality Assurance Consultants in managing department projects, in accordance with company SOPs, guidelines, and national and international regulations. The selected resource will travel to customer sites and serve as a direct point of contact with them. /p pMain responsibilities /p pMaintain systems and processes in compliance with GCP. /p pDraft and/or revise SOPs. /p pManage non-conformities and CAPA. /p pPromote continuous improvement of the quality management system. /p pManage selection and qualification of company suppliers. /p pKeep the internal quality system up to date to ensure compliance with procedures, guidelines, and applicable regulations. /p pReport significant quality gaps and/or risks to upper management and actively participate in problem resolution. /p pBe present during possible inspections by regulatory bodies and external audits (by clients or ISO 9001:2015 a
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