Senior GCP Process Auditor

The company is a Clinical Research Organisation specializing in precision medicine, rare diseases, and oncology, supporting clinical trials with advanced analytics and expert teams.

Location: Romania

Responsibilities

• 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 provide feedback on compliance risks to QA management and identify opportunities for improvement
• Maintains Q&C trackers, databases, metrics, and files
• Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures

Requirements

• Extensive, working knowledge of managing all types of Audits, particularly GCP Process Audits
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards
• Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
• Availability to travel up to 25% domestically and/or internationally

Additional Information

• The ideal candidate will have extensive, working knowledge of managing all types of Audits, particularly GCP Process Audits - candidates without this experience cannot, unfortunately, be considered
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards
• Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
• Availability to travel up to 25% domestically and/or internationally