Clinical QA
Negotiable
/month
Job Description:
1. Internal Audit: Carry out quality management related work for drug clinical trials, including the construction of the quality management system, maintenance, updating, and management of system documents.
2. External Audit: Assist the quality manager in executing audits by external regulatory agencies or clients, including pre-audit inspection arrangements, preparation of audit materials; serve as the main contact person for the audit; assist in completing audit report responses within the specified time after the audit.
3. Training: Provide compliance training for internal and external clients.
4. Supplier Audit: Assist in executing supplier evaluations.
5. Proficient in using quality management tools to ensure that QA daily work complies with SOP requirements, including: non-conformance event management, CAPA management, document change control management, supplier audits, etc.
6. Maintenance of SOPs and training materials, including execution: development, changes, training, and other aspects.
Job Requirements:
1. Bachelor's degree or above in clinical medicine, pharmacy, or related fields.
2. Work Experience: More than 2 years of experience in clinical trial monitoring, more than 1 year of experience in clinical trial QA work, and participation in relevant work as required by this position.
3. Familiar with relevant regulations or systems, such as GCP, GMP, GLP, etc.
4. National Level 4 or above, able to proficiently search and read foreign literature.
5. Strong learning, understanding, logical thinking, communication skills, writing skills, and comprehensive reporting abilities.
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Contact Information
Monday to Friday 9:00~17:00
Rooms 801-808 and 901-908, Building H, No. 3 Jiu Quan Road, Huangpu District, Guangzhou City
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