GMP Senior Auditor

Job Description

• Must Have Radiopharmaceuticals and Quality experience.
• ll others will not be considered.
  *** 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.

• 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 observations and issue formal audit reports.
• Track and verify implementation of corrective and preventive actions (CAPAs).
• Provide guidance on compliance requirements and audit readiness.
• Support regulatory inspections and customer audits.
• Identify systemic issues and recommend process improvements.
• Stay updated on evolving regulatory requirements and industry best practices.

• Bachelor's degree in Life Sciences, Pharmacy, or related field.
• 3-5 years in Radio Pharmaceuticals, with at least 2 years in auditing.
• Strong knowledge of RPT cGMP, GDP, and global regulatory requirements.
• Excellent attention to detail and analytical skills.
• Strong communication and report-writing abilities.
• bility to travel (up to 10%) for audits. Preferred Certifications.
• SQ Certified Quality Auditor (CQA).
• ISO 9001 Lead Auditor.
• GCP/GMP auditing certifications.