Our client is an Italian Biopharmaceutical Company with over a century of history and expertise in the development and commercialization of innovative molecules. We are looking for the
QUALITY ASSURANCE SPECIALIST
About the Company
With a strong history and a commitment to innovation, our client is dedicated to providing innovative drugs in Oncology. As part of an ambitious strategic plan, the Company is expanding its presence and growing in Europe, starting from Italy, which will serve as the Headquarters for the International Operations.
The Opportunity
To enable the Company's growth, we are seeking a talented and experienced Quality Assurance Specialist reporting directly to the International QA Manager, working on the implementation and maintenance of the International Quality Management System fully compliant with GDP and other international guidelines and standards.
Key Responsibilities
* Writing and reviewing Standard Operating Procedures (SOPs)
* Managing quality events such as deviations and related Corrective and Preventive Actions (CAPAs)
* Managing quality technical complaints from the market and change controls
* Supporting the management of returns and recalls from the market
* Supporting the preparation and execution of internal audits and related CAPAs follow-up
* Supporting the preparation and execution of trainings across the countries and the qualification and monitoring of external suppliers' performance
Requisiti
Education and Experience Requirements
* 2-5 years of experience in Quality Assurance in a Pharma Company
* Previous experience supporting the execution of external and internal audits and/or Certification as a Quality Management System Auditor
* Good knowledge of GxP and Quality Management System requirements
Required Skills
* Fluent English (written and spoken)
* Team player with the ability to work independently
* Proactive, well-organized with strong analytical skills, adaptable to changing priorities
* High integrity, confidentiality, and empathy
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