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QA Specialist

Quality Department | Zhongshan, Guangdong, China | Full time | Wednesday 26, 2021

Summary

The quality department consistently produces safe and high-quality products and completes the work of product quality inspection, raw material quality inspection, production supervision and equipment inspection as well as management. The QA specialist is an important member of the quality department. They should assist the manager to establish, standardize, operate and improve the quality management system. Draft management documents of the quality department, review SOP, process procedure and quality standard documents drafted by different departments; Supervise the process of product production, testing and storage; Investigate deviations and changes; Conduct an on-site audit on material suppliers with related departments to evaluate their qualifications; Evaluate the quality of raw materials and packaging materials; Drafting equipment validation plan, and carry out equipment validation according to validation plan; Complete equipment metering/calibration management.


Description

1. Bachelor degree or above, major in biology, pharmacy, pharmaceutical, etc

2. At least 2 years related working experience, familiar with the operation of the pharmaceutical factory, working experience in biological products company and sterile preparation is preferred

3. Familiar with domestic and foreign regulations, such as Chinese GMP and related appendices, CGMP, ICH Q7A, etc

4. Distribute, retrieve, organize and archive quality system documents and records

 

Key Qualifications

1. Familiarity with GMP and related regulations

2. Strong sense of responsibility, excellent execution, and self-management ability

3. College degree or above in pharmacy, biology, or a related discipline with relevant research experience

4. Good computer skills