GCP Quality Auditor performing audits to ensure compliance with GSK policies and Good Clinical Practices. Responsibilities include documenting findings, maintaining knowledge of GCP legislation, and supporting regulatory inspections.
Responsibilities
Independently plan, lead, and conduct routine and complex Quality Assurance audits of GSK studies, systems, processes, and external vendors to assess compliance with GCP, GSK policies, and applicable local regulations
Document objective and process-oriented audit findings in an audit report and ensure robust CAPAs to address findings and their root causes in a timely manner
Report and present findings from audits to relevant stakeholders and provide advice on compliance, quality improvement, and risk assessments
Support regulatory inspections related to GSK
Maintain up-to-date and in-depth knowledge of national and international GCP legislation, guidelines, and relevant GSK processes and procedures
Build and maintain beneficial working relationships with other quality and compliance groups and relevant internal/external customers
Requirements
Bachelor’s degree in a related Health Science field or equivalent
Experience in the pharmaceutical industry and/or quality assurance, including auditing in GCP and/or experience as a Clinical Research Associate
Strong knowledge of Good Clinical Practice (GCP) and global, regional, and national regulatory requirements
Fluent in English, with excellent verbal, written, and presentation skills
Demonstrated analytical skills
Ability and willingness to travel frequently, both domestically and internationally (approximately 25-40%)
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