Global R&D Qa Gcp Specialist Parma

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

Who we are looking forPurposeTo 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 ResponsibilitiesTo 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 GCPTo organise internal trainings on the SOPs related to the QA GCP activitiesTo 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 RequiredPreferably: 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.

EducationScientific degree, Pharmacist or Life SciencesLanguagesEnglish deep knowledge, both oral and writtenTechnical SkillsKnowledge of GCP regulationsUse of common computer tools (e. g.

Office) Soft SkillsCommunication skillsGoal orientationPlanning and organizational skillsStress managementTeam workingWhat 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.