ppIn 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 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.
/pulliannual premio /liliparental leave for 12 weeks /liliinsurance plans /liliStability POC for product families (API and Drug Product) /liliOversee stability sample management /liliAuthor/oversee stability protocols and reports per global SOPs /liliSupport audits and filings related to stability /liliManage stability lifecycle and related questions with PQI/PQO and partners /liliAssist with temperature excursions, change controls,



stability notifications and escalations /liliMaintain stability statements for assigned products /liliCollaborate with Stability Labs to resolve questions timely /liliActive member of Stability CoE supporting departmental goals and process improvements /liliBachelor's degree in a technical/scientific field (Pharmacy, Chemistry, Biology, Biochemistry, Engineering) /liliMinimum 6 years of relevant experience /liliMinimum 4 years in pharmaceutical/biotechnology/medical device industry /liliExperience in API and drug product stability and related business implications /liliUnderstanding of quality systems (change control, CAPA, event handling) and risk management /liliKnowledge of GMP regulatory guidelines and global regulatory requirements /liliAbility to work independently and in teams; strong communication skills /liliWillingness to travel up to 5–10% domestic/international /li /ul /p #J-*****-Ljbffr

📌 Product Quality Specialist (Latina)
🏢 Experteer Italy
📍 Latina