Quality Operations Specialist

Zentiva Group, a.s

Ankleshwar, Gujarat, India
Not specified (assumed to be on-site based on job location).
3 to 6 years pharmaceutical quality experience
Knowledge of stability regulations
Proficiency in sap and edms tools
Zentiva Group is seeking a Quality Operations Specialist for its Ankleshwar, Gujarat location, requiring candidates with a background in pharmacy, medicine, chemistry, or biotechnology, alongside 3-6 years of relevant experience. The role involves ensuring compliance with quality assurance standards, leading product quality reviews, and supporting various quality and regulatory functions

Job Summary

  • The role focuses on leading periodic reviews of products commercialized in Portugal to ensure compliance with corporate guidelines.
  • Responsibilities include managing the complete lifecycle of Product Quality Reviews, from data extraction to trend analysis and KPI calculation.
  • The specialist must maintain strict traceability of evaluations and escalate any delays to the Quality & Compliance Manager immediately.

Matching Summary

Match Score: 85

Zentiva Group is seeking a Quality Operations Specialist for its Ankleshwar, Gujarat location, requiring candidates with a background in pharmacy, medicine, chemistry, or biotechnology, alongside 3-6 years of relevant experience. The role involves ensuring compliance with quality assurance standards, leading product quality reviews, and supporting various quality and regulatory functions.

Skills & Requirements

Must-have

  • 3 to 6 years pharmaceutical quality experience
  • Knowledge of stability regulations
  • Proficiency in SAP and eDMS tools
  • Experience with GxP compliance standards
  • Ability to lead Product Quality Reviews

Nice-to-have

  • Strong analytical data interpretation skills
  • Reactivity and autonomy under pressure
  • Team spirit and open-mindedness
  • Experience with third-party risk assessments
  • Good organizational and decision-making skills

Key Requirements

  • Graduated in Pharmacy, Medicine, Chemistry, or Biotechnology
  • Minimum 3 years experience in pharmaceutical manufacturing sites
  • Fluency in English language required

Work Rights

Not specified

Tailored Resume

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