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崗位職責： 具備3年以上的偏差調(diào)查及報告起草的經(jīng)驗，熟悉偏差調(diào)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(yù)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(jīng)驗，熟悉變更的流程，熟練TrackWise或類似系統(tǒng)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(xié)調(diào)各部門完成偏差調(diào)查。 Have the ability of communication and coordination with other departments. 起草和更新SOP/TWI, 包括批記錄創(chuàng)建和執(zhí)行、模具管理、生產(chǎn)狀態(tài)標識、返工和相關(guān)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(guān)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(xùn)，配合內(nèi)部、外部審計。 Participate in GMP training as required and cooperate with internal/external audit. 按實際業(yè)務(wù)需要支持生產(chǎn)包裝，倉庫打包，收發(fā)貨等庫內(nèi)操作。 Support packaging, warehouse packing, receiving and delivering according to actual business needs. 嚴格遵守和執(zhí)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.