MISSION STATEMENT
To act as quality coordinator for quality alerts investigation and further communication
To act as industrial quality focal point for quality defects and troubleshooting
To act as member of the team for project "Nitrosamine in human medicines" to assure Authorities requests fulfilment and business continuity
To act as qualified GMP auditor for all entities
MAIN ACCOUNTABILITIES AND DUTIES
-
Providing coordination role for quality alerts issues impacting concerned company entities
-
Operational management of the quality alerts in Zentiva QMS system (QualityForward)
-
Coordination of investigation reports compilation, risk confirmation and countries notification, participation on Risk meetings
-
Regular check of authorities websites in regard to new quality alerts detection and their impact on company entities
-
Supervising timely manner execution of quality alerts in scope
-
Support Quality Alerts, Risk Management, and Country Quality related tasks based on manager instruction
-
Providing coordination role for project "Nitrosamines in human medicines", work with nitrosamine database
-
Providing regular reporting in respective areas
-
Acting as qualified GMP auditor for all entities within the company
-
The employee will perform other tasks under the direction of the Manager within the agreed type of work.
REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS
-
Technical University Degree (health, pharma, chemical areas preferred)
-
Knowledge of pharmaceutical GxP regulations and Quality system
-
Good computer skills
-
Fluent English language in writing and speaking (Czech or Slovak language is a strong advantage)
-
Ability to learn / quick adaptability / analytical /organized / communicative
-
Auditing skills
-
Very good communication skills, customer-oriented approach
-
To follow requirements of solid line manager and job description
-
To follow tasks and timelines set for particular activities and projects
What We Do
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.
We are a team of almost 5,000 unique talents bonded together by our mission to deliver high-quality and affordable medicines to people who depend on them every day. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated and can be their true selves contributing to the best of their ability.
