The Position

Main Tasks & Responsibilities主要工作职责 :

1.Set up instrument assembly ,commissioning and packaging equipment, respective organization and

Production process during the project phase.

a. Participation IQ/OQ and engineering run and perform PQ

b. Ensure all processes are defined and described in standard operations procedures (SOPs) and implement manufacturing instructions

c. Build-up operations instrument assembly, commissioning and packaging team

在项目阶段负责仪器组装，测试和包装设备、组织以及生产流程的建立

a. 参与 IQ/OQ 及工程运行并执行 PQ

b. 保证所有流程在 SOP 中被定义和描述,并在生产中进行贯彻。

c. 建立仪器的组装,测试以及包装生产团队

2.Responsible for the hands-on, daily supervision of GMP manufacturing operations and personnel within the

manufacturing site(s).

负责接手,日常监督 GMP 生产车间的生产区域及人员。

3.Lead the team to achieve team target, participate in all aspects of personnel management (training,

coaching and developing).

a. Allocate and balance work across subordinates

b. Review and provide timely performance feedback to subordinates;

c. Mentor, develop and motivate subordinates;

d. Provide technical training and support to sub-ordinate employees;

e. Monitor and implement the company discipline policy

f.Resolve people/functional issues in the production in order to improve effectiveness and achieve targeted

department performance.

g. Provide cross-functional coordination and issue resolution.

领导团队达成团队目标,参与人员管理的相关事宜(培训,指导和发展)

a. 分配及平衡下属的工作

b. 回顾及提供下属的及时反馈

c. 指导,发展及激励下属

d. 提供对下属员工的技术培训和支持

e. 监控和执行公司的纪律政策

f. 解决生产线的人员/功能的问题,以此来提高效率和实现部门的绩效目标

g. 提供跨部门的沟通和问题的解决

4.Monitor work to ensure quality, and continuously promote Quality Right First Time and aim to continuously

improve the efficiency of manufacturing operations

a. implement manufacturing department quality target and monitor the operations quality status ;

b. involve quality issue's analysis and improvement, implement the related action plan.

c. supervise and monitor production process against production plan;

d. monitor emergency solving process in order to ensure smooth production and meet productivity and Quality targets.

监控工作完成,来保证质量以及持续改善产品的一次合格率,持续改进生产效率

a. 贯彻生产部门的质量目标,监控生产质量状态

b. 参与质量问题分析和改善,执行相关的行动计划

c. 根据生产计划监控生产过程

d. 监控异常情况并解决,保证生产顺利进行,达成部门生产率和质量目标

5.Write and revise batch records, SOPs and solution preparation documents to ensure compliance to GMPs.

为达成 GMP 的符合性,完成并修正批记录,SOP,及其它文件的准备

6.Review and approve inventory count plan in order to find out the variance against the standards;

回顾和批准库存盘点计划,及时发现物料的偏差

7.Review workshop's Process Order(PO) and then pass to Finance for further analysis in order to balance all resources

for production

回顾工作中产生的工单,提交给财务部门保证生产物料资源的平衡

8.Schedule manufacturing staff to ensure manufacturing timelines are met

为生产员工指定工作计划来完成及时的生产

9.Review production schedule and priorities to establish shift assignments

回顾生产计划,进行排序,建立班次计划

10.Provide cross-functional coordination and issue resolution

提供跨部门的合作及问题解决

11.Planning & Budgeting

a. Propose and recommend manufacturing strategy;

b. develop and implement production budget and plan;

c. monitor the achievement of the budget; in order to achieve annual manufacturing goals.

计划及预算

a. 对生产策略提供方案和建议

b. 建立并执行生产预算和计划

c. 为实现生产部门的年度目标,监控预算的执行情况

12.Implement Transfer of existing, relevant sending site requirements to fit Suzhou site needs and ensure these

requirements are defined for all positions in the dispenser Operations team

执行从转出工厂进行的转移,从而实现苏州工厂的需求,并保证这些转移能够被所有生产员工所应用

13.Other tasks assigned by line Manager

经理指派的其他任务

Qualification & Experience任职资格:

1.Education 教育背景

College Degree or above, Had the education background of Manufacturing, Engineering or equivalent. Major in Electronic, Electrical or Mechanical is preferred.

大专及以上学历。具有制造，工程或相关专业背景。电子,电气或机械工程专业背景的优先

2.Qualification & Certification 资质证书

a.Experience with SAP

具有 SAP 经验

b.ISO 13485 or cGMP

经过 ISO13485 或 cGMP 培训

3.Experience 工作经验:

a.3 years’ experience in a highly regulated cGMP manufacturing environment

三年高规格 cGMP 环境工作经验

b.6 - 10 years’ experience in manufacturing, including min. 4 years managerial

experience

6-10 年生产经验,不低于四年的管理经验

c.Working experience in medium-to-large-scale enterprise is preferred

具有中大型知名企业工作经验者优先

d.cGMP or medical device experience is preferred

具有cGMP和诊断仪器器械生产工作经验者优先

4.Professional Competencies 专业能力：

a.​​Production Expertise

生产专业知识

b.Professional and positive approach with learning agility

专业和积极学习能力,

c.Self-managed, and can complete assigned tasks independently

能够有效的自我管理，独立完成规定的工作

d.Good team player

具备良好的团队协作精神

e.Effective communicator at project working stream and sub working stream level

能在项目层面已经具体工作层面进行有效沟通，

f.Ability to execute and support the concepts to stream and sub-stream levels

能执行和支持流程以及子流程

g.Assertive, adaptable and creative

自信，适应性强，有创意

h.Dynamic and vigorous, and willing to learn

有活力，有热情，学习意愿强

i.A “can-do” attitude and willingness to go the extra mile when required

具有“可以做”的态度和愿望，在需要时能承担更多任务。

j.Cultural awareness and the ability to work with a broad range of cultures

多文化包容意识，能在多文化平台上工作

k.Fluent in English listening and speaking

流利使用英语进行沟通

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.