北京招聘

生产 及 过程 控制 工程师 /质量工程师/Quality Engineer/QA工程师/QC工程师

主要工作职责 Key Responsibilities: ( 概括关键职责、每项职责所要达成的结果 /primary deliverables of

roles)

1. Identify applicable requirements from GxP regulations, industry standards, policies from

AQR/ARDx/BU with support from SME.

在总部及外部顾问的帮助下，识别 GxP 相关法规，标准及总部相关政策要求。

2. Understand the improvement opportunities for PPC workstream, evaluate the risk of improvement

opportunities and provide professional improvement advice to the company.

理解识别出的改进机会，评估相关风险，提供专业的改进建议。

3. Provide support to PPC workstream remediation planning, execute the activities in accordance with

plan and report out the deliverables and exception.

参与制定改进计划，执行改进措施，汇报工作结果及异常。

4. Evaluate the production and process control (PPC) process, which may include facility,

environment, equipment, repair & maintenance, calibration, process validation, training &

qualification, production planning, work order, material flow, information flow, acceptance activities

of IQC/IPQC/FQC, DMR, WI/SOPs, DHR, OpEX activities and drive the correction and

improvement activities, document the result.

评估 PPC 过程 (包括但不限于厂房设施，生产环境，洁净室，生产机器设备/工装，维护及维护保

养， 校验，过程验证，培训及资质考核，生产计划，工单，物料流，信息流， QC 检验活动，

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DMR， WI/SOP, DHR, OpEX 等)， 推动改善活动，记录改善活动结果。

5. Lookback DHR and other quality records, evaluate the risk and propose the actions.

回顾 DHR 等质量记录，评估风险，落实改进措施。

6. Update applicable WI/SOPs if necessary.

更新 SOPs

7. Provide professional support and trainings to stakeholders where necessary.

为相关方提供专业的技术指导及培训。

8. Drive the PPC process improvement program if necessary.

推动过程验证流程改善项目。

9. Track and measure the implementation of PPC remediation actions.

跟踪及测量改进措施落实情况。

10. Join the meeting, conference call and summarize the report etc.

参加会议，电话会议。按要求准备各种会议资料，报告等。

11. Undertake other tasks that assigned by superior.

完成上级安排的其他任务。

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