仕事詳細
医薬品の品質管理試験を実現するための担当業務を遂行する。
Perform chemical test and particulate matter test for the following, and manage the data.
•manufacturing support system
•raw material receiving test
•initial test for each mixed solution after mixing immediately
•in-process test
•final product test (including particulate matter test)
•imported products test (including particulate matter test)
•stability test / monitoring
•plastic container test
Prepare and review the SOPs and forms. And do test and review the test result to follow the quality requirements faithfully.
Prepare the protocol to install equipment and analytical method. And execute the validation and issue the final report.
Prepare the protocol for stability test/monitoring and execute the tests and issue the final report.
Perform OOS investigation and CAPA activities.
Perform maintenance activities to avoid trouble on equipment and fix the problem when troubles happen.
Strictly follow Baxter quality policy and related regulation and guideline.
Schedule control and execution of tests, calibration, periodical inspection and maintenance for equipment.
Complete the tests in a timely manner. (including understanding of analytical technique and principals)
Train associates and give suggestion as mentor.
Purchase reagents, test solution and standards based on current inventory and expiry.
Participate in EMS activities.