Sr. Quality Operations Specialist

Zentiva Group, a.s

Ankleshwar, Gujarat, India
Remote
Pharmaceutical manufacturing sites experience
Stability regulations knowledge
Gxp know-how
Zentiva Group is seeking a Sr. Quality Operations Specialist with 5-8 years of experience in Quality or Regulatory Affairs within the pharmaceutical sector. The role, primarily focused on ensuring compliance and leading product quality reviews, is based in Ankleshwar, Gujarat, India, and involves collaboration with various teams

Job Summary

  • The Sr. Quality Operations Specialist will support the Quality Assurance and Compliance function to ensure compliance with applicable requirements and Corporate Zentiva guidelines.
  • This role focuses on leading periodic reviews of products commercialized in Portugal and ensuring the traceability and archiving of evaluations.
  • Responsibilities include preparing trend analyses, KPI calculations, data compilation from IT tools, and supporting deviation investigations and inspections.

Matching Summary

Match Score: 85

Zentiva Group is seeking a Sr. Quality Operations Specialist with 5-8 years of experience in Quality or Regulatory Affairs within the pharmaceutical sector. The role, primarily focused on ensuring compliance and leading product quality reviews, is based in Ankleshwar, Gujarat, India, and involves collaboration with various teams.

Skills & Requirements

Must-have

  • pharmaceutical manufacturing sites experience
  • stability regulations knowledge
  • GxP know-how
  • analytical data interpretation
  • Quality Forward, Share/DrugTrack, eDMS, SAP usage

Nice-to-have

  • organizational skills
  • stress resistance
  • flexibility
  • team player
  • decision-making
  • reactivity
  • autonomy
  • sense of urgency
  • open-mindedness

Key Requirements

  • 5 to 8 years minimum experience in Quality or Regulatory Affairs
  • 3+ years experience in pharmaceutical manufacturing sites
  • Graduated/post-graduate in Pharmacy/Medicine or Chemistry/Biotechnology
  • English speaker

Work Rights

Not specified

Tailored Resume

Cover Letter