Zentiva is a renowned manufacturer of high-quality and affordable medicinal products, catering to patients across Europe and beyond. With a dedicated workforce of over 4,700 employees and a robust network of manufacturing facilities—including flagship sites in Prague, Bucharest, and Ankleshwar—Zentiva aims to become a leader in branded and generic medicines in Europe. Driven by the belief that healthcare should be a right and not a privilege, Zentiva collaborates with healthcare professionals, pharmacists, regulators, and government bodies to provide accessible healthcare solutions.
Key Responsibilities in the Job
As a Quality Alert Expert, your main mission is to ensure seamless coordination and management of quality alerts, industrial quality issues, and regulatory requirements. Your responsibilities will include:
- Quality Alerts Coordination: Oversee the operational management of quality alerts in the Zentiva QMS system (QualityForward). This involves coordinating investigation reports, risk confirmations, and country notifications, as well as participating in risk meetings.
- Monitoring Authorities’ Websites: Regularly check regulatory websites to detect new quality alerts and assess their impact on Zentiva entities.
- Project Participation: Act as a core team member for the “Nitrosamine in Human Medicines” project, ensuring compliance with authority requests and maintaining business continuity.
- Auditing Responsibilities: Serve as a qualified GMP auditor for all Zentiva entities, ensuring adherence to pharmaceutical GxP regulations and quality systems.
- Reporting and Task Execution: Provide regular updates on quality alerts, risk management, and related areas. Execute tasks and timelines as directed by the manager.
Required Qualifications
To excel in this role, you must meet the following qualifications:
- Education: A degree from a technical university, preferably in health, pharmaceutical, or chemical fields.
- Regulatory Knowledge: Familiarity with pharmaceutical GxP regulations and quality systems.
- Language Skills: Proficiency in English (written and spoken). Czech or Slovak language skills are a strong advantage.
- Auditing Skills: Demonstrable expertise in conducting GMP audits.
Essential Skills
The ideal candidate will possess the following skills:
- Technical Proficiency: Strong computer skills to handle quality management systems and reporting tools.
- Analytical and Organized: Quick adaptability and analytical thinking to assess risks and manage projects effectively.
- Communication: Excellent interpersonal skills and a customer-oriented approach.
- Problem-Solving: Ability to coordinate and troubleshoot quality defects efficiently.
