Job Summary
A biotechnology company has an open position for a Telecommute GVP GCP Compliance Auditor.
Core Responsibilities Include:
- Managing and assisting in implementing and maintaining a comprehensive risk-based GVP/GCP compliant quality program
- Assisting in setting annual audit schedule and preparing necessary budget
- Managing and conducting external site, vendor, and commercial partner audits
Must meet the following requirements for consideration:
- Up to 50% travel may be required
- Bachelor’s degree in a science related field
- 6+ years of relevant pharmaceutical industry experience which includes 3+ years of Pharmacovigilance/GVP auditing or operations experience or 3+ years of direct GCP auditing experience
- Knowledge of a risk-based auditing approach to assuring compliance
- Ability to provide guidance regarding global GVP/GCP compliance regulations
- Familiar with a Company Pharmacovigilance Summary Master File document with the ability to contribute towards required audit-related information
