Validation Specialist

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Sommario

Il Team Convalide riporta al Dipartimento Qualità e supporta la produzione e tutte le attività del Valtellina Plant.

Descrizione del ruolo:

• Condurre e gestire attività di validazione per garantire che equipment/processi/sistemi computerizzati rimangano in stato convalidato nel tempo
• Redigere protocolli/report di convalida di processi/equipment/utilities e sistemi computerizzati (IQ/OQ/PQ) in compliance con le normative applicabili
• Eseguire attività di validazione in ambiente di produzione e analisi statistica dei dati
• Collaborare in progetti relativi a nuove installazioni e lavorare in team multifunzionali
• Gestire attività quali CAPA/PA e non conformità relative all’ufficio validazioni
• Rivalutare periodicamente lo stato di convalida dei processi e delle attrezzature

Requisiti:

• Laurea in Ingegneria, Farmacia, Biologia o affini
• Precedente esperienza in ambito validazione, preferibilmente in contesto farmaceutico
• Ottime capacità relazionali, organizzative e di team building
• Buona conoscenza dei principali applicativi Office
• Buona conoscenza della lingua inglese scritta e parlata
• Conoscenza di nozioni base di statistica

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.