Qa Gcp Specialist Milano

Qa Gcp Specialist
Milano
Lombardia, Milano

Jefferson Wells is looking for a GCP QA Specialist on behalf of an Italian pharma company based in Milano.

Culturally embedded in clinical project teams, he/she ensures support to Clinical Operations so that the processes relating to Clinical Trials are conducted in accordance with current national and international legislation, the relevant guidelines, and Dompé standard operating procedures. He/she contributes to the organization and continuous improvement of the procedural system in the field of Clinical Trials. He/she ensures, in agreement with the function manager, the planning and coordination of development projects and initiatives aimed at improving the QMS level.

All the activities of competence relating to the management of the quality system in the field of clinical trials mentioned below are intended to be applied both to medicinal products and to medical devices.

Duties Description:In relation to the studies panel assigned, participates in Clinical Project Teams and represents the relevant contact point for study teams, providing continuous support to CLINOPS&DEV throughout the study conduction. Supports internal departments of the Company for the interpretation of the ICH GCP and reference regulations. In relation to the studies panel assigned, reviews the study documentation and issues related QA documents. Ensures the definition and implementation of a Quality Metrics / KPIs & Inspection Readiness model. Ensures oversight and participation in the management and continuous improvement of the GCP System. Contributes to the identification, design, and implementation of QA GCP improvement projects both at system and digitalization level. Contributes to the development and updating of the Standard Operating Procedures relating to clinical trials in order to ensure compliance with the reference regulations (GCP), assisting the Quality System function in designing, maintaining, and updating the overall Quality management system. Supports the drafting and updating of the Standard Operating Procedures relating to quality assurance activities for clinical trials. Provides assistance/support during inspections by Regulatory Authorities in the GCP area. Assists in the coordination of external consultants for GCP quality assurance activities. Supports the planning and execution of periodic GCP training, also following GCP regulatory updates. Supports the Management in the definition, allocation, and management of Department projects/initiatives budget. Ensures compliance with the law and regulations in compliance with the provisions of the control model pursuant to and for the purposes of Legislative Decree 231/01 and the codes of conduct within its area of responsibility. Ensures compliance with legal obligations and procedures regarding occupational safety and hygiene as well as environmental protection within its area of responsibility.

#J-18808-Ljbffr