偏差变更建立人员

岗位职责：
具备3年以上的偏差调查及报告起草的经验，熟悉偏差调查的流程，能够准备的找到根本原因（root cause），从而制定正确的纠正预防措施（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.
具备2年以上变更管理经验，熟悉变更的流程，熟练TrackWise或类似系统的操作。
There are 2 years’ experience on change control management, familiar with the operation of TrackWise or similar systems.
具备一定的沟通能力，能够协调各部门完成偏差调查。
Have the ability of communication and coordination with other departments.
起草和更新SOP/TWI, 包括批记录创建和执行、模具管理、生产状态标识、返工和相关流程等文件。
Draft and update SOP/TWI, including batch record creation and execution, mould management, production status identification, rework and related processes.
参与相关文件的编写工作，使得文件比较高的可操作性。
Participate in the preparation of relevant documents, make the documents relatively high operability.
按要求参与GMP培训，配合内部、外部审计。
Participate in GMP training as required and cooperate with internal/external audit.
按实际业务需要支持生产包装，仓库打包，收发货等库内操作。
Support packaging, warehouse packing, receiving and delivering according to actual business needs.
严格遵守和执行公司所以的政策和程序。
Strictly follow and implement all company policies and procedures.
与部门同事和上级保持有效沟通，完成上级交代的其他工作。
Maintain effective communication with department colleagues and superior, complete other tasks assigned by superior.