Auditor - Pv

csl.co.th

Not specified
Pharmacovigilance audit execution
Gvp regulatory knowledge
Capa development and risk categorization
CSL Seqirus is seeking a Pharmacovigilance Auditor to oversee audits within their Research & Development Quality program. The role requires expertise in regulatory compliance and audit management in drug safety operations, along with strong communication and analytical skills

Job Summary

  • This role serves as a PV Auditor responsible for executing the global audit plan to ensure the accuracy of safety data and compliance with legal standards.
  • The position requires conducting audits of external partners and internal safety functions to identify findings and non-compliance trends impacting the reliability of the pharmacovigilance system.
  • CSL Seqirus is part of CSL, one of the largest influenza vaccine providers in the world, offering state-of-the-art production facilities across the U.S., U.K., and Australia.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a Pharmacovigilance Auditor to oversee audits within their Research & Development Quality program. The role requires expertise in regulatory compliance and audit management in drug safety operations, along with strong communication and analytical skills.

Skills & Requirements

Must-have

  • Pharmacovigilance audit execution
  • GVP regulatory knowledge
  • CAPA development and risk categorization
  • External vendor auditing experience
  • Internal self-inspection management

Nice-to-have

  • Multinational team collaboration
  • Strong negotiation skills
  • Analytical problem-solving abilities
  • SOP improvement initiatives
  • Signal management expertise

Key Requirements

  • BS degree in biological science or pharmacy
  • Quality Assurance experience in GVP-regulated environment
  • Audit and inspection management expertise
  • Ability to travel up to 50%

Work Rights

Not specified

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