Course Assistant (“Missione CRA” Training Program)
Per il seguente ruolo potrebbero essere richieste diverse soft skill ed esperienze. La preghiamo di consultare attentamente la panoramica riportata di seguito.
Job details
Work location: Mesagne (BR), hybrid or full-remote.
Schedule: Full-time.
Contract: CCNL Commercio (starting RAL €35k). The gross annual salary (RAL) will be commensurate with the experience of the selected candidate.
About us
ClinOpsHub 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 15.11.2011 (CRO Decree).
ClinOpsHub 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.
In 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.
Main responsibilities
Maintain systems and processes in compliance with GCP.
Draft and/or revise SOPs.
Manage non-conformities and CAPA.
Promote continuous improvement of the quality management system.
Manage selection and qualification of company suppliers.
Keep the internal quality system up to date to ensure compliance with procedures, guidelines, and applicable regulations.
Report significant quality gaps and/or risks to upper management and actively participate in problem resolution
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