Milano - Junior quality assurance specialist
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
JUNIOR QUALITY ASSURANCE SPECIALIST
About the Company: With a strong history and a commitment to innovation, our client is dedicated to provide 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 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 to GDP and other international guidelines and standards.
Key Responsibilities:
- Standard Operating Procedures SOPs writing and review
- Management of quality events such as deviations and related Corrective and Preventive Actions (CAPAs)
- Management of quality technical complaints from the market and change controls
- Support the management of returns and recall from the market
- Support the preparation and execution of internal audits and related CAPAs follow up
- Support the preparation and execution of trainings across the Countries and the qualification and monitoring of the external suppliers performance
Education and Experience Requirements:
- at least 2 years of experience in Quality Assurance in a Pharma Company
- Previous experience in supporting the execution of external and internal audits and/or Certification as Quality Management System Auditor
- Good knowledge of GxP and Quality Management System requirements
Required Skills:
- English fluent (written and spoken)
- Team player with ability to work independently
- Proactive, very well organized with strong analytical skills, flexible to adapt to changing priorities
- High integrity, confidentiality and empathy