Product quality specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7h09hm

In this role, you will own stability management across Late Stage to commercialization for a product portfolio. You'll support PQI/PQO and contribute to the Stability Co E, 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 premio parental leave for 12 weeks insurance plans Stability POC for product families (API and Drug Product) Oversee stability sample management Author/oversee stability protocols and reports per global SOPs Support audits and filings related to stability Manage stability lifecycle and related questions with PQI/PQO and partners Assist with temperature excursions, change controls,



stability notifications and escalations Maintain stability statements for assigned products Collaborate with Stability Labs to resolve questions timely Active member of Stability Co E supporting departmental goals and process improvements Bachelor's degree in a technical/scientific field (Pharmacy, Chemistry, Biology, Biochemistry, Engineering) Minimum 6 years of relevant experience Minimum 4 years in pharmaceutical/biotechnology/medical device industry Experience in API and drug product stability and related business implications Understanding of quality systems (change control, CAPA, event handling) and risk management Knowledge of GMP regulatory guidelines and global regulatory requirements Ability to work independently and in teams; strong communication skills Willingness to travel up to 5–10% domestic/international #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7h09hm