Sr. Auditor

Sr. Auditor needs 35 years in Radio Pharmaceuticals, with at least 2 years in auditing.

Sr. Auditor requires:

Skills: cGMP, GDP, FDA, EMA, ICH, RPT cGMP, regulatory inspections, customer audits, CAPA, deviations, change controls, audit planning, audit checklists, audit schedules, audit reporting, process improvements, compliance requirements, audit readiness, report writing, analytical skills, communication skills, pharmaceutical quality system (PQS), auditing, ISO 9001, GCP, GMP, ASQ Certified Quality Auditor (CQA)

• Bachelors degree in Life Sciences, Pharmacy, or related field.

• Strong knowledge of RPT cGMP, GDP, and global regulatory requirements.

• Excellent attention to detail and analytical skills.

• Strong communication and report-writing abilities.

• Ability to travel (up to 10%) for audits.

• ASQ Certified Quality Auditor (CQA)
• ISO 9001 Lead Auditor
• GCP/GMP auditing certifications

Sr. Auditor duties:

• 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.