Zentiva
1001 - 5000 employees
Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We offer solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.
Quality Specialist, Complaints
🕒 May 26
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Zentiva
1001 - 5000 employees
Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We offer solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.
📋 Description
• Develop and ensure compliance with quality plans and programs • Implement regulatory compliance in cooperation with the Regulatory Affairs Manager • Monitor Group quality standards and their implementation in the local QMS • Record and initially assess reported cases of drug risks or suspected pharmaceutical-technical defects • Collaborate and serve as a point of contact for other departments regarding complaints
🎯 Requirements
• Experience in coordinating regulatory inspections under manufacturing and wholesale distribution licenses • Knowledge of regulatory compliance • Ability to monitor Group quality standards and local QMS implementation • Skills in recording and assessing reported cases of drug risks • Capability to collaborate with Customer Service, KAMs, and Medical Information
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