QA Auditor

About the role

IQVIA is looking for a QA Auditor in Beijing to assist lead auditors and audit liaisons in conducting, hosting and reporting quality assurance audits. The role performs specific audit tasks under the direct supervision of more senior QA staff.

Key responsibilities

• Schedule, conduct, report and close quality assurance audits within budget and timelines, including contacting auditees to agree on dates, entering entries in the QA database, performing data reviews and file audits
• Enter and categorize audit and inspection findings in the eQMS, and solicit follow-up information to close findings
• Review and approve Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans
• Support investigators' derogatory status management in the database, prepare and release guidance documents with compliance information, and maintain the QA repository for such investigators
• Assist in hosting customer audits, mock regulatory inspections and regulatory facility inspections as a scribe, reviewing documents, calling operational staff and handling administrative duties such as tracking reviewed documents and scheduling interview sessions
• Obtain a fundamental knowledge of current GLP regulations, guidelines and auditing techniques, provide QA consultancy where possible, and maintain the eQMS and support the audit lifecycle

Required profile

• Bachelor's degree preferred; equivalent combination of education, training and experience accepted
• 1 year of quality assurance experience in pharmaceutical, technical or a related area, including GXP and/or quality assurance experience
• Strong interpersonal, problem-solving, organization, communication and teamwork skills
• Ability to work independently, manage multiple projects and build effective working relationships with coworkers, managers and clients

Required skills

• Knowledge of GXP regulations and quality assurance auditing techniques
• Word processing, spreadsheet and database applications
• Familiarity with GLP regulations and guidelines