GMP Senior AuditorKatalyst Healthcares and Life Sciences • Paramus, NJ, United States
GMP Senior Auditor
Katalyst Healthcares and Life Sciences • Paramus, NJ, United States
[job_card.variable_days_ago]
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- [job_card.full_time]
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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.
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GMP Senior Auditor • Paramus, NJ, United States
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