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GMP Senior Auditor
GMP Senior AuditorKatalyst Healthcares and Life Sciences • Paramus, NJ, United States
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GMP Senior Auditor

GMP Senior Auditor

Katalyst Healthcares and Life Sciences • Paramus, NJ, United States
28 days ago
Job type
  • Full-time
Job description
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.
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 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.
Requirements:
  • 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.
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GMP Senior Auditor • Paramus, NJ, United States

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