Auditor - Pv

CSL Seqirus

**
Gvp-regulated environment experience
External audit execution skills
Drug safety operations knowledge
** CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to execute audits and ensure compliance within their global drug safety network. The ideal candidate will have experience in quality assurance within a GVP-regulated environment and will be responsible for identifying non-compliance trends and developing corrective actions. **

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 identifying non-compliance trends and systematic risks within the PV discipline to protect the integrity of the Pharmacovigilance System Master File.
  • CSL Seqirus is 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: 75

** CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to execute audits and ensure compliance within their global drug safety network. The ideal candidate will have experience in quality assurance within a GVP-regulated environment and will be responsible for identifying non-compliance trends and developing corrective actions. **

Skills & Requirements

Must-have

  • GVP-regulated environment experience
  • External audit execution skills
  • Drug safety operations knowledge
  • Risk categorization expertise
  • CAPA development capabilities

Nice-to-have

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

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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