Manager - Quality Operations

Zentiva Group, a.s

Ankleshwar, Gujarat, India
10 to 14 years experience in quality or regulatory affairs
8+ years experience in pharmaceutical manufacturing sites
Knowledge of stability regulations application
The role focuses on leading periodic reviews of products commercialized under Zentiva Quality Operations authorization

Job Summary

  • The role focuses on leading periodic reviews of products commercialized under Zentiva Quality Operations authorization.
  • Responsibilities include ensuring traceability of Product Quality Reviews, calculating KPIs, and managing deviation investigations.
  • Candidates must possess strong organizational skills and the ability to work autonomously with a sense of urgency.

Matching Summary

The role focuses on leading periodic reviews of products commercialized under Zentiva Quality Operations authorization.

Skills & Requirements

Must-have

  • 10 to 14 years experience in Quality or Regulatory Affairs
  • 8+ years experience in pharmaceutical manufacturing sites
  • Knowledge of stability regulations application
  • Proficiency with IT tools like SAP and Quality Forward
  • Strong analytical data interpretation skills

Nice-to-have

  • Experience in pharmaceutical biotech industry
  • Good level of GxP know-how
  • Reactivity autonomy with sense of urgency
  • Open-mindedness and team spirit
  • Stress resistance and flexibility

Key Requirements

  • Graduated/post-graduate in Pharmacy Medicine Chemistry or Biotechnology
  • Minimum 10 to 14 years total experience in Quality or Regulatory Affairs
  • Minimum 8 years experience specifically in pharmaceutical manufacturing sites
  • English language proficiency required

Work Rights

Not specified

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