Global R&D Qa Gcp Specialist Parma

Global R&D Qa Gcp Specialist
Parma
Emilia Romagna, Parma

To ensure GCP compliance within the project teams, acting as QA reference person for clinical project teams. To ensure the implementation and maintenance of the quality system in the GCP areas. Main Responsibilities Act as QA member in the clinical project teams, providing QA inputs and supporting the clinical study teams in the design, execution, and reporting of clinical studies. Review the documents related to clinical studies (protocol/amendment, patient information sheet/Informed consent form, CTS label, CTS instruction for use). Review the SOPs and working instructions related to the clinical studies, in order to ensure compliance with current regulations. Write the SOPs and working instructions related to the activities performed by R&D QA GCP. Organize internal trainings on the SOPs related to the QA GCP activities. Manage the GCP deviations. Manage the GCP changes. Support the preparation, management, and follow-up of GCP inspections from Regulatory Authorities. Participate in projects aimed at improving the quality management system, such as deployment of new systems, implementation of new processes, and/or new regulatory requirements. Experience Required Preferably: At least 3 years' experience as clinical QA in pharmaceutical companies or clinical CROs. Alternatively: At least 3 years' experience in clinical studies working as CRA or Project Manager in pharmaceutical companies or clinical CROs. Education Scientific degree, Pharmacist, or Life Sciences. Languages Deep knowledge of English, both oral and written. Technical Skills Knowledge of GCP regulations. Use of common computer tools (e. g. , Office). Soft Skills Goal orientation. Planning and organizational skills. Stress management. What We Offer You would join a dynamic, fast-growing, challenging, and friendly environment. In Chiesi, we firmly believe that our people are our most valuable asset , which is why we invest in continuous training, learning, and development. 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 give our best. That is why we offer a flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services. J-18808-Ljbffr