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1、Responsible for QC personnel management, including personnel recruitment, training, performance appraisal, daily work arrangement, etc., to continuously improve workflow and increase efficiency.
2、Responsible for the management of QC documentation system, responsible for the development of the department's management procedures, review laboratory related SOPs, testing methods, quality standards, validation programs, etc.
3、Supervise the validation (confirmation) of testing instruments and methods in this department to ensure the correctness of test results.
4、Responsible for ensuring that the necessary inspection is completed before the release of materials and products to confirm that they meet the quality requirements.
5、Responsible for the timely and accurate issuance of inspection reports in this department, responsible for the audit of the inspection report form.
6、Responsible for the management of QC related projects and ensure that the projects are completed as planned.
7、Ensure the effective operation and continuous optimization of the quality control management system.
8、Responsible for supervising and participating in the department's change, CAPA, laboratory OOS/OOT/abnormal testing data related investigations.
9、Responsible for ensuring the integrity, reliability and authenticity of QC lab data.
10、Complete other tasks assigned by the supervisor.
1、Bachelor degree or above in chemistry, biology, pharmacy or other related majors.
2、master the principle and operation of the test; familiar with the description of drug GMP norms, domestic and international pharmacopoeia related tests.
3、Good English reading ability and proficiency in computer operation.
4、5 years or more working experience in pharmaceutical companies and more than 2 years of management experience.