制剂QA Formulation Quality Assurance(J13563)

工作职责 Act as the basic executor for quality assurance activities, perform daily/weekly/monthly on-site inspection and reviewing on the operation area, operation and behaviors, document and record during the product manufacturing, stop and correct the operation or behavior which does not meet cGMP and internal SOP requirement, train the related operator and report to QA management. 作为质量保证工作的基础执行者，对产品制造和质量体系运行过程中的相关现场、操作和行为、文件和记录进行每日/每周/每月动态巡查和复核，对违反cGMP规范要求及公司SOP要求的操作和行为予以制止和纠正，对相关人员进行培训，并向QA管理层报告。 Review the quality related documents and records generated during the manufacturing of product and running of the quality system, communicate the findings with the responsible person for correction and follow-up the correction until its closure. 按照相应SOP要求，复核产品制造和质量体系运行过程中产生的质量相关文件和记录，对发现的问题与责任人沟通并监督其予以纠正和整改，直至关闭。 Ensure appropriate testing/inspection on the materials, packaging component, process aids and the test/inspection results meet the established spec. 确保产品生产所使用的原辅料、包装材料、工艺辅助用品等经过了适当的检测/检查并且符合既定的规格要求。 Responsible for the collection and summarize of quality documents such as deviation, change control and CAPA ./负责偏差、变更、CAPA等质量文件的收集、汇总。Participate the preparations for readiness of customer QA audit and cGMP regulatory inspection. 参与客户QA审查和cGMP法规检查的相关准备工作。 Perform periodically quality review and trend analysis (include the annual product review) on the responsible quality assurance activities. 定期执行相应质量保证工作的质量回顾和趋势分析（包括年度产品质量回顾）。 任职资格 1、硕士学历，制药相关专业； 2、英语听说读写能力良好，可作为工作语言 1. Master’s degree in Pharmacy‑related disciplines; 2. Good command of English in listening, speaking, reading and writing, capable of using English as a working language.