- Prepare, conduct QA audits, generate audit reports, communicate results to relevant departments, and interacts with various teams to ensure corrective and preventative actions are taken to bring audit observations to closure as applicable.
- Provide GCP and/or GVP compliance interpretation, consultation, training.
- Support the development of SOPs to ensure alignment with local laws and regulations. Participate in the development/enhancement of QA procedures, guidance documents and audit tools.
- Maintain quality system platform with quality system specialists.
- Bachelor or above in Medical, Pharmacy or related majors, a minimum of 5 years’ experience in clinical trial with at least 2 years’ experience in QA.
- GCP certificate and training certificates on QA.
- Familiar with clinical procedures and good knowledge of GXP.
- Know well of management system and quick start in system-related work after training.
- Good English written and speaking skills. Proficient in Microsoft Office applications.
- Strong logical thinking, good communication skills and learning ability, strong text editing and summary ability.