Global PV-Systems Auditor - Galesburg, ND, United States - Horizon Group

Horizon Group
Horizon Group
Verified Company
Galesburg, ND, United States

2 weeks ago

James Miller

Posted by:

James Miller

beBee Recruiter
Freelance
Description
Your Responsibilities

  • Managing and conducting internal PV audits in Galesburg, ND
  • Developing and implementing PV audit strategies in collaboration with the QPPV and R&D departments
  • Ensuring GVP audits are conducted at external sites and internal departments
  • Monitoring processes and systems to ensure compliance with internal and external GVP requirements
  • Defining CAPAs in collaboration with the QPPV office and PV operations teams
  • Reviewing and approving audit responses both internally and externally
  • Acting as a subject matter expert during global regulatory agency inspections and other IT office audits related to GVP compliance
Your Background

  • Bachelor's degree in natural sciences or equivalent education
  • Minimum of 7 years of experience in the pharmaceutical industry
  • Ideally, 5 years of experience in pharmacovigilance/GVP
  • Excellent knowledge of global GVP, GCP, and quality risk management regulations and guidelines
  • Experience with computer system validation
  • Experience writing comprehensive audit reports and documentation for management and other supporting areas
  • Excellent written and verbal English language skills
Your Benefits

  • A modern workplace in Galesburg, ND
  • Exciting opportunities in a growing company
  • Challenging and diverse projects
  • A multicultural and highly professional team
  • A collegial corporate culture with open communication channels
  • Flexible working hours and an attractive salary package
  • Various corporate benefits
Note on Gender
For the sake of readability, the use of male, female, and diverse (
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