1. Responsible for the organization and coordination of abnormal product events at the production site, to ensure that product deviations, changes, and CAPAs are effectively handled, including acceptance, putting forward handling opinions, supervising implementation, tracking and closing;
2. Ensure that product documents: process specifications, verification plans/reports, BPRBCR, etc. are effectively reviewed and meet the requirements;
3. Responsible for on-site inspection of products, ensuring that on-site process operations, hygiene, identification, customization, production records and auxiliary records meet the requirements, and promoting the rectification of non-conforming items;
4. Ensure that product production related verification, including process verification, cleaning verification, etc., supervise the verification process as required;
5. Ensure that deviations, non-conformities and change actions related to release have been effectively dealt with before product release;
6. Ensure that product complaints and returns in the production area are investigated in a timely manner;
7. Conduct regular environmental monitoring of the production clean area;
8. Participate in product quality review.

1. More than 2 years of experience in quality management in pharmaceutical enterprises; More than 3 years of experience in aseptic production.
2. Familiar with ICH and GMP related regulations and quality management system, and have participated in FDA or GMP certification;
3. Good communication, organization and coordination skills;
4. Able to adapt to night shifts;
5. Cross-team collaboration, communication and coordination skills, excellent planning and execution skills.