Sr. Auditor

Paramus, NJ - USA

Hourly Salary: $ 65 - 67

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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

Sr. Auditor requires:

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.
35 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.
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.

Sr. Auditor needs 35 years in Radio Pharmaceuticals with at least 2 years in auditing. Sr. Auditor requires: 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 compl...