GMP Auditor
JOB DESCRIPTION
We are seeking a highly experienced GMP Auditor to support audit preparation and execution for a release and stability laboratory located in Souderton, PA. The ideal candidate will bring deep familiarity with FDA regulations and strong auditing skills focused on 21 CFR Part 210/211 and ICH Q7 Guidelines. This part-time consulting role will require planning and executing the audit in November writing the audit report, and providing debrief support.
The Role:
Lead audit preparation activities for a GMP release and stability laboratory inspection.
Conduct a comprehensive on-site audit on November 10th, 2025, evaluating compliance with applicable regulatory standards.
Draft and finalize detailed audit reports, documenting observations and recommendations.
Participate in audit debriefs and assist in follow-up communications as needed.
Required Skillset
5+ years of hands-on experience performing GMP audits.
Strong knowledge of 21 CFR Part 210/211 and ICH Q7 guidelines.
Proven ability to write clear, detailed audit reports.
Availability to support audit preparation prior to November and complete documentation and debrief activities post-audit.
Prior Experience specifically in audits involving drug product release and stability testing