Clinical QA Specialist

3 settimane fa


Milano, Lombardia, Italia Jefferson Wells A tempo pieno

At Jefferson Wells, we are seeking a highly skilled QC Clinical GCP Specialist to join our team. This key role is responsible for ensuring that clinical trials are conducted in accordance with current national and international legislation, guidelines, and company standard operating procedures. The Quality Assurance Specialist will be responsible for the organization of the procedural system in the field of clinical trials, working closely with the function manager to plan and coordinate the execution and follow-up of audits.

Main responsibilities:

  • Contributes to the development and updating of Standard Operating Procedures relating to clinical trials to ensure compliance with reference regulations (GCP), assisting the Quality System function in designing, maintaining, and updating the overall Quality management system;
  • Supports the drafting and updating of 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 assesses the implementation status of corrective and preventive actions;
  • Evaluates the effectiveness of 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.

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