Corporate R&D QA, Senior PV Auditor

Purpose

•    To verify that the quality system implemented both at Corporate and Affiliate level is coherent and compliant with internal procedures and regulatory requirements.
•    To ensure continuous improvement of the quality processes at Corporate and Affiliate level with regard to Pharmacovigilance.

Main Responsibilities

•    To manage PV Audits to Chiesi Pharmacovigilance System (PV System and PV process Audits to Global Pharmacovigilance and Affiliates, PV Audits to Business Partners, PV Qualification and Maintenance Audits to Service Providers, PV Audit to PASS), including the risk-based planning, the audit conduction and the monitoring of the CAPA implementation;
•    To cooperate in the selection and management of the PV QA Service Providers;
•    To review the PV SOPs related to the PV System to ensure harmonization and compliance with current regulations and corporate requirements;
•    To write SOPs/WIs related to the PV Audits  activities;
•    To cooperate in the planning and execution of PV Audit trainings to Global and Affiliates PV personnel;
•    To cooperate in the maintenance and the quality review of the PSMF, according to the task assigned by PV QA Manager;
•    To act as QA PV partner providing expert inputs in the projects/activities for GPV and Chiesi affiliates personnel;
•    To cooperate to manage quality metrics for PV Audits 

Experience Required

The ideal profile should have at least 3 years experience as PV Auditor in Pharmaceutical Companies or as PV Auditor Consultant involved in international project. 
As alternative, at least five year experience in Global PV System management in pharmaceutical companies or in PV Service Providers.

Education

Scientific Master’s degree

Languages

English fluent 

Technical Skills

• Knowledge of GVP and ISO principles 
• Knowledge of PV Quality Management Systems in Headquarters of international pharmaceutical companies
• Knowledge of the pharmacovigilance processes of Global PV System
• Knowledge of auditing technique
• Knowledge of training technique

Soft Skills

• Stress management
• Decision making
• Leadership and social influence
• Team working
• Quality orientation