Quality Auditor supporting Quality Assurance by facilitating product transfers and auditing finished goods in Neosho distribution center. Involvement in maintaining productivity records and assisting with line testing.
About the role
- GVP Auditors supporting compliance reviews across GCP clinical sites and vendors in Japan. Prepare detailed reports and collaborate with clients to ensure quality standards.
Responsibilities
- Conduct Good Pharmacovigilance Practice (GVP) audits (planning, agenda, physical or remote audit, and report writing)
- Evaluate investigator sites, CROs, and vendor compliance or qualification.
- Prepare comprehensive audit reports detailing findings and root-causes.
- Provide written audit reports in English.
- If required will provide corrective actions support and present findings to QA leadership and stakeholders
- Work collaboratively with clients to ensure quality standards.
Requirements
- Minimum 10+ years of Clinical Quality Assurance and/or Pharmacovigilance Practice (GVP) experience.
- Minimum 5+ years of Pharmacovigilance Practice (GVP) auditing experience.
- Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
- Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
- B2 level in English communication, verbal and written
- B2 level in Japanese communication, verbal and written
- Bachelor's degree
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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