GxP Compliance Consultant
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Job Summary
To support GxP compliance activities, the remote CSA Consultant will provide expertise in Pharmacovigilance, Clinical, and Regulatory Affairs systems, ensuring systems are implemented and maintained in compliance with applicable regulations.
Key Responsibilities
- Provide CSA/CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms
- Develop and review validation deliverables including Validation Plans, Risk Assessments, and Validation Summary Reports
- Conduct periodic system compliance reviews and assessments to ensure ongoing regulatory compliance
Required Qualifications
- 5-8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, or Regulatory Affairs
- Strong understanding of CSA principles, CSV, and SDLC processes
- Experience authoring and/or reviewing validation documentation
- Working knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data integrity expectations
- Ability to work independently in a fast-paced, matrixed environment
Complete Job Description
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