GMP Senior Auditor
7 days ago
- 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.
-
GCP Auditor/Senior
4 days ago
Paramus, NJ, United States Actalent Full timeGCP Auditor/Senior (Sr.) Auditor, Quality Assurance Apply for the GCP Auditor/Senior Auditor, Quality Assurance role at Actalent. Job Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's...
-
GCP Auditor/Senior
1 day ago
Paramus, NJ, United States Actalent Full timeGCP Auditor/Senior (Sr.) Auditor, Quality Assurance Apply for the GCP Auditor/Senior Auditor, Quality Assurance role at Actalent. Job Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's...
-
Sr. Auditor
7 days ago
Paramus, NJ, United States Headsbase Consulting Full timeJob Title: Sr. Auditor Duration: 5 months Job Summary: 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...
-
Sr. Auditor
2 weeks ago
Paramus, NJ, United States Headsbase Consulting Full timeJob Title: Sr. Auditor Duration: 5 months Job Summary: 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...
-
Sr. Auditor
2 weeks ago
Paramus, NJ, United States Headsbase Consulting Full timeJob Title: Sr. Auditor Duration: 5 months Job Summary: 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...
-
Sr. Auditor
1 week ago
Paramus, NJ, United States Headsbase Consulting Full timeJob Title: Sr. Auditor Duration: 5 months Job Summary: 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...
-
GCP Senior Auditor
2 weeks ago
Paramus, NJ, United States Together We Talent Full timeJob Description GCP Senior Auditor Paramus, NJ (Hybrid) Contract Mid-Senior Level Ensure GxP compliance, quality oversight, and audit excellence for a fast-growing biopharmaceutical company advancing neurology and psychiatry therapies. A rapidly growing biopharmaceutical organization is seeking an experienced GCP Senior Auditor to support Quality Assurance...
-
GCP Auditor/Senior
2 weeks ago
Paramus, NJ, United States Actalent Full timeJob Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's compliance directives. This position supports quality management systems to minimize risks in a regulated pharmaceutical environment....
-
GCP Auditor/Senior
2 weeks ago
Paramus, NJ, United States Actalent Full timeJob Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's compliance directives. This position supports quality management systems to minimize risks in a regulated pharmaceutical environment....
-
GCP Auditor/Senior
6 days ago
Paramus, NJ, United States Actalent Full timeJob Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's compliance directives. This position supports quality management systems to minimize risks in a regulated pharmaceutical environment....
