About Chiesi
Chiesi is an international pharmaceutical and healthcare group based in Parma, Italy. With over 85 years of experience, the company operates in 31 countries and has more than 7,000 employees. Chiesi aims to improve people's quality of life by acting responsibly towards society and the environment.
The company researches, develops, and markets innovative drugs in its main therapeutic areas. Chiesi is proud to be the largest global pharmaceutical group to receive B Corp Certification, recognizing high social and environmental standards.
The company values its people and promotes a strong set of shared Values and Behaviors. It believes that diversity enriches its culture and strives to attract and retain talented individuals who embody these values.
Job Description
Pharmacovigilance Quality Assurance (PV QA) Auditor
We are seeking a qualified individual to verify that our quality system is coherent and compliant with internal procedures and regulatory requirements. The successful candidate will ensure continuous improvement of quality processes at both corporate and affiliate levels.
The ideal candidate should have at least three years of experience as a PV Auditor in pharmaceutical companies or as a PV Auditor Consultant involved in international projects. Alternatively, they may have five years of experience in global PV System management in pharmaceutical companies or in PV Service Providers.
Main Responsibilities:
* Manage PV Audits to Chiesi Pharmacovigilance System, including risk-based planning, audit conduction, and CAPA implementation monitoring.
* Cooperate in the selection and management of PV QA Service Providers.
* Review PV SOPs related to the PV System to ensure harmonization and compliance with current regulations and corporate requirements.
* Write SOPs/WIs related to PV Audits activities.
* Cooperate in the planning and execution of PV Audit trainings to Global and Affiliates PV personnel.
* Act as QA PV partner providing expert inputs in projects/activities for GPV and Chiesi affiliates personnel.
* Manage quality metrics for PV Audits.
Required 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.
We offer a dynamic, fast-growing, challenging, and friendly environment. We invest in continuous training, learning, and development, promoting employee growth and well-being.