Analysis of the inspector
1. The formulation, revision and maintenance within the QC (quality test center) system and the operational procedures, review all related to QC (quality test center) operation procedures.
2. To ensure the normal operation of the laboratory accords with GMP and CGMP, management system, as well as SOP and management system of the company;
3. Responsible for the organization to establish, formulate and revise the experimental materials, intermediate products and finished products (production) process of internal control standards, inspection methods (discipline) and standard operating procedures, is responsible for the inspection method, validation and documentation, handle the technical problems in QC;
4. Responsible for making equipment, instruments, reagents, reagent, standard substance and reference substance, standard solution, culture medium and so on management system, and implementation of management;
5. Product inspection record and report the examination and approval
6. In the process of evaluation test abnormalities, OOS and OOT investigation, OOS and OOT investigation;
7. Not on a regular basis for QC (quality test center) internal self-inspection;
8. To help analyze the abnormal situation in production workshop;
9. To do a good job of internal and external communication and coordination, ensure the QC (quality test center) to complete the test task on time with good quality, sample inspecting and stability;
Arrange subordinates collaboration, pushing forward the construction of the department staff selection, equipment, staff training, guidance, evaluation, enhance the overall quality of the subordinates.
11. Other temporary work.
1. Bachelor degree or above in the checkout room or laboratory management work full 3 years of above, college degree to work in the checkout room or laboratory management with more than 5 years
2. To master relevant knowledge and skills drug inspection; Master the pharmacopoeia, GMP and other relevant laws and regulations.
3. Has a strong organization and coordination ability, judgment and problem solving ability;
4. Has strong team cooperation ability and team leadership;
5. At the same time with solid preparation, sterile injection and API quality system experience is preferred.
6. Pharmaceutical, chemical, pharmaceutical, pharmaceutical analysis, chemical analysis or related major, bachelor degree or above
7. Good oral and written English