Product Quality Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gtj0z

In this role, you will own stability management across Late Stage to commercialization for a product portfolio.
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You'll support PQI/PQO and contribute to the Stability CoE, ensuring high-quality stability data, protocols, and reports.
You collaborate with global teams to address stability questions, audits, and regulatory expectations.
The position offers exposure to end-to-end product quality in a global, customer-centered organization known for healthcare innovation.annual bonusparental leave for 12 weeksinsurance plansStability POC for product families (API and Drug Product)Oversee stability sample managementAuthor/oversee stability protocols and reports per global SOPsSupport audits and filings related to stabilityManage stability lifecycle and related questions with PQI/PQO and partnersAssist with temperature excursions, change controls,



stability notifications and escalationsMaintain stability statements for assigned productsCollaborate with Stability Labs to resolve questions timelyActive member of Stability CoE supporting departmental goals and process improvementsBachelor's degree in a technical/scientific field (Pharmacy, Chemistry, Biology, Biochemistry, Engineering)Minimum 6 years of relevant experienceMinimum 4 years in pharmaceutical/biotechnology/medical xysqume device industryExperience in API and drug product stability and related business implicationsUnderstanding of quality systems (change control, CAPA, event handling) and risk managementKnowledge of GMP regulatory guidelines and global regulatory requirementsAbility to work independently and in teams; strong communication skillsWillingness to travel up to 5–10% domestic/international
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gtj0z