QA Specialist

Department: Global R&D Quality Assurance

Team: Quality

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas.

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.

Who we are looking for

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 projects.
As an alternative, at least five years experience in Global PV System management in pharmaceutical companies or in PV Service Providers.

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 techniques
• Knowledge of training techniques

Soft Skills

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

What we offer

You 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 approaches, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.