Reporting directly to the International QA Manager, the QA Specialist will support the QA Manager in the implementation and maintenance of the International Quality Management System (QMS) with the mission of providing an effective and efficient QMS fully compliant to current GMP, GDP and other international guidelines and standards to ensure products are appropriate to their intended use and to the Marketing Authorization and product specification.
The QA Specialist tasks include but are not limited to:
* Writing, review and dissemination of Standard Operating Procedures SOPs
* Management of quality events such as deviations and related Corrective and Preventive Actions (CAPAs)
* Management of quality technical complaints from the market
* Support the management of returns and recall from the market
* Management of change controls
* Support the preparation and execution of internal audits and related CAPAs follow up
* Support the preparation and execution of trainings across the countries
* Support the management of external suppliers: qualification and monitoring of performance including the revision of Quality Technical Agreements
* Support the management of customer qualification process
* Support the revision of Product Quality Reviews (PQRs)
* Support the preparation and execution of International Quality Management Reviews
* Participation in support to the external audits received by Regulatory Authorities and/or Certification Bodies when applicable
* Support the preparation and/or review of validation reports (eQMS)
* Collaboration with internal and external stakeholders
Work experience requirements:
* 3-6 years of experience in Quality Assurance in a multinational pharmaceutical company, preferably in a commercial environment
* Previous experience in supporting executing external and internal audits and/or Certification as Quality Management System Auditor
* Deep knowledge of GxP and Quality Management System requirements
* Fluent written and spoken English
* Team player with ability to work independently
* Very well organized, objective oriented with time and priority management without losing attention to details
* Proactive, strong analytical skills, flexible to adapt to changing priorities
* High integrity, confidentiality, empathy and personal tact
Offer details:
* Work location: Milan
* Direct hire with a permanent contract
* On-site cafeteria
* Smart working (1 day)
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