Quality Alert Expert

at  Zentiva Group as

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

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

• 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.