We are collaborating with a large Pharmaceutical client in San Diego to grow their Quality team by finding their next Quality Compliance Auditor. You would be conduct and manage internal and external GMP audits ensuring compliance with their GxP Audit program!
RESPONSIBILITIES
- Prepare GxP external audit reports with thorough notes regarding any observations of non-compliance
- Assist with regulatory and partner inspections when needed
- Create and author SOPs
- Recommend CAPAs as needed to support compliance within your department
- Manage and maintain Quality Agreements
REQUIREMENTS
- At least 1 year of relevant GMP Quality audit experience
- Working knowledge of GCP and GLP regulations and requirements
- Strong understanding of Quality Agreements
- Strong verbal and written communication skills