Jefferson Wells is looking for a QC Clinical GCP Specialist on behalf of a pharmaceutical company based in Milano (Lombardia).
The QA GCP Specialist ensures support so that the processes relating to Clinical Trials are conducted in accordance wlth current national and International leglslatlon, the relevant guldellnes and company's standard operating procedures.
He/she is responsible for the organization of the procedural system in the field of Clinical Trials.
He/she ensures, in agreement with the function manager, the planning and coordination of the execution / follow-up of the audits and supports the Clinical Operations teams for Quality issues.
Furthermore, 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.
Main responsibilities: ? 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 and clinical investigations on DM; ? Supports planning, coordination or conducting GCP audits of clinical trials processes; ? Verifies audit reports and audit certificates in the case of consultant audits; ? Evaluates the completeness and appropriateness of corrective action plans; ? Periodically assess the implementation status of corrective and preventive actions; ? Evaluates the effectiveness of the preventive and corrective actions implemented (internal audits only); ? Supports the planning, coordination or conduct of follow-up audits, if necessary; ? Provides assistance/support during inspections by Regulatory Authorities in the GCP area; Supports internal departments of the Company for the interpretation of the ICH GCP and reference regulations; ? Assists in the coordination of external consultants for GCP quality assurance activities; ? Supports the planning and execution of periodic GCP training; ? Supports planning and execution of training following GCP regulatory updates; ? Supports the Management in 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.
