Global R&D Qa Gcp Specialist Parma

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

Department: Global R&D Quality Assurance Team: Quality Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7, 000 employees. To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas. We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels. We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors. Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Who we are looking for Purpose To ensure the GCP compliance within the project teams, acting as QA reference person clinical project teams. To ensure the implementation and maintenance of the quality system in the GCP areas. Main Responsibilities To 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. To review the documents related to clinical studies (protocol/amendment, patient information sheet/Informed consent form, CTS label, CTS instruction for use). To review the SOPs and working instructions related to the clinical studies, in order to ensure the compliance with the current regulations. To write the SOPs and working instructions related to the activities performed by R&D QA GCP. To organise internal trainings on the SOPs related to the QA GCP activities. To manage the GCP deviations. To manage the GCP changes. To support the preparation, management and follow-up of GCP inspections from Regulatory Authorities. To participate in projects aimed to the improvement of 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 English deep knowledge, 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 , 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. J-18808-Ljbffr