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Senior GCP Auditor
3 months ago
Key Responsibilities
- Maintain and update the Clinical Trial Quality Management System to align with industry standards, guidance, and best practices.
- Contribute to the development and review of Standard Operating Procedures (SOPs) and other controlled documents, including forms, templates, and work instructions.
- Ensure compliance with SOPs and ICH GCP E6 (R2) standards.
- Manage the incident management program by monitoring complaints, deviations, and Corrective and Preventive Actions (CAPAs).
- Schedule, plan, coordinate, and conduct vendor/supplier audits, internal audits, compliance visits, for-cause audits, and clinical trial site audits.
- Prepare necessary documentation to support audit activities, including audit plans, audit reports, audit certificates, and corrective action plans.
- Validate the accuracy of audit findings and produce written audit reports and follow-up activities to ensure non-compliance issues are satisfactorily resolved.
- Review final audit documents for accuracy.
- Review trial-related documents such as protocols, protocol amendments, Informed Consent Forms (ICFs), pharmacy manuals, and Clinical Study Reports (CSRs).
- Apply regulations, guidance document requirements, and study protocol requirements to clinical trial studies.
- Participate in resolving Good Clinical Practice (GCP) compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
- Support collaborative efforts in training on company procedures, GCP regulations, and documentation systems to ensure compliance with company policies and regulatory standards.
- Maintain all associated Quality Assurance (QA) department spreadsheets for tracking deviations, CAPAs, complaints, audit findings, and audit files, as applicable.
- Lead development and implementation efforts for continuous inspection readiness.
- Assist senior staff during regulatory inspections or other audits.
- Represent the QA department at internal and external meetings supporting clinical programs.
- Perform other quality-related duties as assigned.
Education & Experience
- Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment; or a Master’s Degree in a life sciences or engineering discipline with a minimum of 4 years of experience in a GCP-Biologics or Pharmaceutical environment.
- Certified Quality Auditor (CQA) or other audit certifications are advantageous.
- Prior experience with Trial Master File (TMF) or electronic document management systems is beneficial.
