$ads={1}
Location: Czech Republic, Prague
Job purpose:
- 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
Your responsibilities:
- Providing coordination role for quality alerts issues impacting concerned company entities
- Operational management of the quality alerts in Zentiva QMS system (TrackWise)
- 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
- Support Quality Alerts and Risk Management based on Manager instruction
- Supervising timely manner execution of quality alerts in scope
- Providing coordination role for project "Nitrosamine in human medicines", nitrosamine database administration
What we require:
- Technical University Degree (health, pharma, chemical areas)
- Knowledge of pharmaceutical GxP regulations and Quality system
- Knowledge and active usage of MS office
- Fluent English language in writing and speaking
- Ability to learn / quick adaptability / analytical /organized / communicative
- To follow tasks and timelines, set for particular activities and projects
- To work independently, to be proactive
- Experience with nitrosamines, and/or other genotoxic impurities topics is a big advantage
- Experience in internal/external auditing is advantage
What we offer:
- International, successful company
- An opportunity to grow further within company structure
- An opportunity to broaden your knowledge and expertise in your field
- Continuous language and personal development
- Flexible working hours
- An attractive compensation & benefits package (home office, sick days, five weeks holidays …)
$ads={2}
