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Salary: 400,000 CNY

Company Overview

A multinational company specializing in the manufacturing and trading of apis and intermediates.Phase I production of bulk drugs and intermediates, phase ii production of preparations.The first phase is divided into two steps. The first step is the registered capital of 50 million us dollars, and the total investment is nearly 80 million us dollars. The factory of producing bulk drugs and intermediates with an annual output of 2,500 tons will be built.

Job Description

Ensure that all the samples are tested properly and tests are finished on time.Manage all the QC activities according to the GMP requirements.Organize the OOS investigation and dealing with all the deviations in QC.Review and approve Batch Analysis Records (BARs).Finally approve the batch COAs.Release some raw materials and intermediates.Organize the continuous stability studies.Cooperate with R&D department, to participate methods transfer of new projects;Review and approve the specification, analytical procedures and QC relevant SOPs.Manage the QC instruments and organize the qualification or calibration of instruments according to VMP.Ensure that analytical methods are validated properly.

Requirements

Pharmaceutical or Chemical or Instrument analysis or similar background (college or above).More than 8 years’ experience in Quality control related job.Have Drug GMP relevant knowledge and practical implementation experience, e.g. cGMP, EU-GMP, State GMP.