Senior GCP Process Auditor
About the role
About Precision for Medicine
Precision for Medicine is a Clinical Research Organisation. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
Senior GCP Process Auditor
As our company continues to grow, we are seeking a GCP Process Auditor to join our team.
As a Process Auditor, you will support the audit program and clinical projects to ensure compliance with regulations and Precision procedures. You will be responsible for providing oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study.
Essential functions of the job include but are not limited to:
- Support the Quality Management System including SOPs, training and CAPA
- Process and maintain documentation for controlled documents, as required
- Develop and administer training for employees and/or consultants
- Host client/sponsor audits and support regulatory inspections
- Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
- Coordinate and conduct internal audits of quality systems
- Coordinate and conduct investigator site audits
- Coordinate and conduct trial master file audits
- Participate on computer systems validation projects and systems change control process
- Provide QA consultation and support to assigned project teams internally and externally
- Support and manage reported quality issues and any associated corrective and preventive actions
- Monitor quality systems to pro