Doc Auditor responsible for processing and reviewing closing - related documentation at ServiceLink. Supports Doc Auditors and ensures compliance with company and client requirements.
About the role
- 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%)
Benefits
- Health insurance
- Professional development opportunities
- Paid time off
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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