Auditor - Pv

CSL Seqirus

Not specified (assumed hybrid based on industry norms).
Gvp regulatory compliance knowledge
External vendor audit execution
Drug safety operations experience
CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to ensure compliance with drug safety regulations and quality standards through audits of external partners and internal processes. The ideal candidate will possess extensive experience in quality assurance within regulated environments and exhibit strong analytical and communication skills

Job Summary

  • This role executes the global audit plan to ensure accuracy of safety data and compliance with legal standards.
  • The position involves conducting audits of external partners and internal safety functions to identify non-compliance trends.
  • CSL Seqirus offers a culture of inclusion and belonging that fuels innovation in pandemic preparedness.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a Pharmacovigilance (PV) Auditor to ensure compliance with drug safety regulations and quality standards through audits of external partners and internal processes. The ideal candidate will possess extensive experience in quality assurance within regulated environments and exhibit strong analytical and communication skills.

Skills & Requirements

Must-have

  • GVP regulatory compliance knowledge
  • External vendor audit execution
  • Drug safety operations experience
  • CAPA development and risk categorization
  • 50% travel requirement

Nice-to-have

  • Multinational team collaboration skills
  • Systemic risk trend analysis
  • SOP improvement initiatives
  • Strong negotiation abilities

Key Requirements

  • BS degree in biological science or pharmacy
  • Quality Assurance experience in GVP-regulated environment
  • Audit expertise in pharmacovigilance discipline

Work Rights

Not specified

Tailored Resume

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