Moving Science Closer to Health
Senior GCP Process Auditor
Location
Poland
Posted
9 days ago
Salary
0
Seniority
Senior
Job Description
Senior GCP Process Auditor
Precision Medicine Group
• 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
Job Requirements
- 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
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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