NPI Project Associate Manager

Abbott Laboratories (Shanghai, 中国) 11天前发布

主要职责Major Responsibilities: 

总体职责:

领导新产品从第三方工厂或雅培内部工厂向上海工厂的新产品导入项目使之顺利进行

Lead New Product Transfer (NPI) project successfully from TPM/ internal manufacture sites to Shanghai site

完成产品相关的工艺评估。

Complete the product related assessment on time.

协同各个部门共同制定新产品导入策略

Work with related functions to finalize NPI strategy.

保证新产品导入所有的活动符合目标市场和雅培政策的要求。

Make sure all the activities of NPI are in line with policy and target marketing requirement

跟踪并协调新产品导入的项目计划,确保达到项目里程碑。          

Follow up and coordinate the new product project plan to ensure the project milestone is achieved.

参与工程批、验证批的生产和准备工作,与产品专家合作对新产品生产过程中出现的工艺相关问题提供技术解决方案。

Be involved in the preparation and manufacturing of engineer batch and validation batch, deliver technical solution for process related problems for new product by working with SMEs.

参与产品获批后的首批商业化生产和供应项目,确保产品按计划上市。

Be part of the project team for commercial launch.

负责新产品导入相关文件的准备。

Responsible for NPI related documentation preparation.

实施过程中负责相关参与人员的培训。

Responsible for the training of related people during the implementation.

新产品导入实施后的经验总结和流程的持续改进;

Lesson learn after NPI project implementation and continuous improvement of NPI process.

通过数据分析,结合专业知识,在产品上市后提出和实施工艺改进方案。

Through data analysis with professional knowledge, propose and execute process improvement projects after product launch.

负责协调新产品导入所需生产设备/备件的寻源、采购、安装、调试和验证

Responsible for coordinating the sourcing, purchasing, installation, commission and qualification of the process equipment& parts for NPI project.

在NPI实施过程中起草,并及时完成工艺相关的异常报告。

Assist to initiate and finish Exception Report in time during NPI implementation.

支持新产品导入内外部审计。

Supporting on NPI internal/external audits.

作为工厂与全球技术平台和其他全球职能之间的联络人,邀请和征求相关专家的支持,并有效利用全球技术社区的技术知识。

Act as a liaison between the manufacturing plant personnel and global technology platforms and other global functions to engage and solicit the support of relevant subject matter experts and leverage the technical knowledge across the global technical community.

在风险评估和产品生命周期管理中应用前瞻性的过程分析。

Apply proactive process analysis in risk assessment and product life cycle management

利用精益六西格玛工具和方法,确定和领导流程改进和获取价值的机会。

Identify and lead process improvement and value capture opportunities by utilizing lean six sigma tools and methodologies.

完成生产经理交给的其它工作。

Any other work assigned by production manager.

文件 Document

制定新产品引进的策略文件TTP。工艺规程和批制造记录。

Generate NPI strategy document TTP. MTD/MO/MD/FO/FD for NPI.

制订或修改新产品导入及现有产品的技术文件。

Initiate or revise NPI and existing product related technical documentation.

制订或修改MTD,MO/MD,FO/FD 及相关工程批/验证批文件。

Generate MTD, MO/MD, FO/FD and related engineer/validation documents.

准时完成新产品导入生产批记录的审核及各类生产统计。

Review the NPI batch records and other kinds of production statistics.

按需及时完成新产品导入相关汇总报告。

Timely complete the NPI summary report as needed.

支持注册文件的准备。

Supporting on dossier preparation.

协调下列主要现场职责

确保有资质的人员进行操作。

Ensure qualified people performs operation.

确保在新产品生产使用前生产区域及设备处于清洁状态。

Make sure production area and equipment in production areas are clean before NPI production.

严格遵从方案,SOP/MD/FD操作。

Operate strictly as protocol, SOP and MD/FD。

及时向部门和QA如实汇报制造过程中的异常情况 。

Truthfully report to production department and QA the exception events during manufacturing and process in time.

负责监督生产部操作人员现场的操作时符合EHS的要求。

Supervise on-site operations to be line with the company and corporate EHS policies and requirements

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NPI Project Associate Manager

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