Lead QA Engineer, Fast Trak

1. Maintain and optimize the quality management system in Fast Trak China:

a. Conduct quality events management, including deviation, CAPA, change control, OOS/OOT;

b. Conduct document management, including the drafting, revision, review, distribution, periodic review, archiving, retention and obsoleting, etc.;

c. Organize annual quality management review, develop remediation plan and follow up the corresponding the action implementations.

2. Conduct reviewing of relevant validation documents (validation protocol and validation report) in Fast Trak China;

3. Conduct the internal audit in Fast Trak China in accordance with the requirements of quality management system;

4. Coordinate and host the external on-site audit by the 3rd party audit firms, government agencies or clients;

5. Supporting the production services for IND applications and earlier clinical phase trail in Fast Trak China to meet the requirements of IND applications and clinical phase trail:

a. Conduct reviewing of batch manufacturing record, batch testing record and batch testing report, RoA, CoA, protocol & report for stability study & method validation/qualification;

b. Release materials;

c. Conduct reviewing of standardization protocol and report for reference standard;

d. On-site supervision.

6. Provide necessary quality training to all staffs in Fast Trak China;

7. Participate in supplier on-site audit related to Fast Trak China to ensure meet the Fast Trak China requirement of supplier qualification.

8. Other assigned tasks.

Requirements:

1. Bachelor’s or master's degree is required, preferably in microbiology, cell biology, molecular biology, biochemical or chemical engineering, or related field.

2. A minimum of 10 years working in biopharmaceutical or pharmaceutical or industry inclusive of Quality Assurance or Quality Engineering experience. Prior upstream/downstream experience in drug biomanufacturing is preferred.

3. Understanding of drug manufacturing QMS requirements and regulatory requirements including but not limited to NMPA regulations, FDA 21 CFR 210 & 211, PIC/S and application to the manufacture of biopharmaceuticals.

4. Exceptional analytical, problem solving & root-cause analysis skills.

5. Good English written and verbal communication skills.

6. Demonstrated collaboration & conflict resolution skills.

7. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies.