QC Specialist / Supervisor
The Quality Department produces safe and high-quality products consistently. They complete the work of product quality inspection, raw material quality inspection, production supervision and equipment inspection management. The QC specialist is an important member of the Quality Department, they should assist the manager to establish the standard operation 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 deviation 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.
1. Responsible for the sampling of raw materials, packaging materials, process water, etc
2. Responsible for the inspection of raw materials, auxiliary materials, packaging materials, process water, intermediate products and finished products within the inspection cycle
3. Responsible for laboratory reagent test solution, retention sample, stability test sample management
4. Complete the retention sample, stability inspection variety inspection
5. Cooperate with the company to complete the verification of the related inspection work
6. Responsible for the maintenance and verification of laboratory equipment
7. Be responsible for environmental monitoring in the clean area
8. Responsible for the management of all measuring instruments related to the quality of the laboratory, and carry out regular inspection of measuring instruments
9. Complete other tasks assigned by superior.
1. College degree or above, major in pharmacy, pharmaceutical analysis or related
2. At least 3 years quality inspection experience in pharmaceutical manufacturing enterprise, familiar with sampling, physicochemical inspection, biochemical analysis, methodological confirmation/verification of drugs and raw materials. Solid laboratory practice management experience, GMP certification or audit experience is preferred. Familiar with high performance liquid phase, ultraviolet, infrared light precision instrument.