崗位職責： 具備3年以上的偏差調查及報告起草的經驗，熟悉偏差調查的流程，能夠準備的找到根本原因（root cause），從而制定正確的糾正預防措施（CAPA）There are 3 years’ experience on deviation investigation and report drafting, familiar with procedure of investigation, the root cause can be defined correctly and the corrective action and preventive action can be taken. 具備2年以上變更管理經驗，熟悉變更的流程，熟練TrackWise或類似系統的操作。 There are 2 years’ experience on change control management, familiar with the operation of TrackWise or similar systems. 具備一定的溝通能力，能夠協調各部門完成偏差調查。 Have the ability of communication and coordination with other departments. 起草和更新SOP/TWI, 包括批記錄創建和執行、模具管理、生產狀態標識、返工和相關流程等文件。 Draft and update SOP/TWI, including batch record creation and execution, mould management, production status identification, rework and related processes. 參與相關文件的編寫工作，使得文件比較高的可操作性。 Participate in the preparation of relevant documents, make the documents relatively high operability. 按要求參與GMP培訓，配合內部、外部審計。 Participate in GMP training as required and cooperate with internal/external audit. 按實際業務需要支持生產包裝，倉庫打包，收發貨等庫內操作。 Support packaging, warehouse packing, receiving and delivering according to actual business needs. 嚴格遵守和執行公司所以的政策和程序。 Strictly follow and implement all company policies and procedures. 與部門同事和上級保持有效溝通，完成上級交代的其他工作。 Maintain effective communication with department colleagues and superior, complete other tasks assigned by superior.