Job Summary:

The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes.

Key Responsibilities:

• Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers.


• Prepare detailed audit plans, checklists, and schedules.


• Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines.


• Review and approve deviations, CAPAs, and change controls.


• Document audit observation...