Manager - Quality Operations

The Manager - Quality Operations will support the Quality Assurance and Compliance function of Zentiva Quality Operations to ensure compliance with applicable requirements and Corporate Zentiva guidelines. The role will focus on leading periodic reviews of products commercialized under the Zentiva Quality Operations authorization.

Requirements

• Graduated/post-graduate in Pharmacy/Medicine or Chemistry/Biotechnology
• 10 to 14 years minimum experience in Quality or Regulatory Affairs
• Experience obtained in pharmaceutical manufacturing sites (+8 years)
• Knowledge of stability regulations and its application to the industry
• Skilled in the usage of IT tools (for example: Quality Forward, Share/DrugTrack, eDMS), SAP
• English speaker
• Good organizational skills, stress resistance, and flexibility
• Good Team player and good in decision-making
• Interpretation/Analytical data
• Experience in the pharmaceutical/biotech industry with a good level of GxP know-how is a strong plus
• Reactivity, autonomy with a sense of urgency and priorities
• Open-mindedness and team spirit