Auditor - Pv

CSL Seqirus

Not specified, likely hybrid or onsite based on the nature of the role and travel requirement.
Global audit execution for pv vendors
Drug safety operations knowledge
Gvp regulatory framework expertise
CSL Seqirus is seeking a PV Auditor to execute audits within their Research & Development Quality program, ensuring compliance with pharmacovigilance standards. The ideal candidate will possess experience in quality assurance within a GVP-regulated environment and strong 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 pharmacovigilance system.
  • CSL Seqirus is one of the largest influenza vaccine providers globally, offering state-of-the-art production facilities and a culture focused on inclusion and belonging.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a PV Auditor to execute audits within their Research & Development Quality program, ensuring compliance with pharmacovigilance standards. The ideal candidate will possess experience in quality assurance within a GVP-regulated environment and strong analytical skills.

Skills & Requirements

Must-have

  • Global audit execution for PV vendors
  • Drug safety operations knowledge
  • GVP regulatory framework expertise
  • Risk categorization and CAPA development
  • Trend analysis in pharmacovigilance

Nice-to-have

  • Collaborative stakeholder engagement skills
  • Ability to work with limited supervision
  • Experience with multinational teams
  • Strong problem-solving capabilities
  • Commitment to systemic stability

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter