SENIOR QUALITY ASSURANCE AUDITOR
Title: Senior Quality Assurance Auditor
Department: Regulatory Affairs and Quality Assurance
Location: Chengdu, China
Reports to: Director of Regulatory Affairs and Quality Assurance, CSO
Qualifications:
Bachelors Degree in a related science (Biology, Chemistry, etc.) and a minimum of 5 years related
regulatory/QA experience, preferably in the pharmaceutical/biotechnology industry
Basic understanding of Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs)
Good Manufacturing Practices (cGMPs), especially as related to the pharmaceutical/biotechnology industry and
the ability to communicate understanding to others
Experience in performing QA/Regulatory Compliance audits
Working knowledge of applicable US-FDA regulations and guidelines to include ICH guidelines
Strong computer skills, i.e., MS Word, Excel, PowerPoint
Excellent verbal and written communication skills; fluency in Chinese highly preferred
Attend Continuing Education to enhance proficiency in GXPs (GLP, cGMP, and GCP)
Maintain active memberships in quality assurance and regulatory societies
Specific Responsibilities:
Perform quality assurance auditing of toxicology and analytical studies to include protocol review, data review,
in-life inspections, report review and post-audit reviews
Attend pre-initiation, and pre-necropsy (when appropriate) meetings on internal studies
Work closely with toxicology and analytical staff in addressing quality assurance needs in a professional and
positive manner
Conduct subcontractor inspections and evaluate and pre-certify CROs and vendors for GXP compliance
Ensure compliance with GLP, GCP, and GMP
Participate in internal and external GXP training activities
Assist in assembly and preparation of appropriate documents for submission to regulatory agencies
Contribute directly to the preparation of IND sections, and support IND filing process in collaboration with a
multi-disciplinary professional and administrative staff
Collaborate with Division staff in specific project related assignments (e.g., labeling and manufacturing issues)
Participate in development of departmental and divisional SOPs
Assist with special QA projects and other duties as assigned
Provide leadership and mentoring to junior staff members
