QA Specialist

1 settimana fa


Milan, Italia Istituto Gentili A tempo pieno

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 stakeholdersWork experience requirements3-6 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 tactOffer detailsWork location: Milan Direct hire with a permanent contract On-site cafeteria Smart working (1 day)Informativa breve al trattamento dei dati personali ai sensi dell’art. 13 del Regolamento (UE) 2016⁄679 Ai sensi dell’art. 13 del Regolamento (UE) 679⁄2016 (General Data Protection Regulation, in seguito per brevità GDPR o Regolamento), La informiamo che i Suoi dati personali da Lei liberamente conferiti saranno trattati da Istituto Gentili S.r.l., con sede in Via San Giuseppe Cottolengo n. 15, 20143 - Milano, in qualità di Titolare del trattamento, esclusivamente per lo svolgimento di attività di selezione e valutazione del personale nell’interesse della Società. La base giuridica legittimante il trattamento è l’art. 6, paragrafo 1, lett. b), GDPR. I Curricula ricevuti saranno conservati per il tempo necessario a valutare la candidatura e saranno eliminati qualora la candidatura dovesse essere respinta. Per esercitare i diritti riconosciuti dagli articoli 15 e ss. del GDPR può contattare il Titolare del trattamento scrivendo a o il Responsabile della Protezione dei Dati scrivendo a #J-18808-Ljbffr


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