Main Tasks & Responsibilities 主要工作职责 :

* Fulfill daily output ensuring production targets are met also meets the
quality request and delivery date committed to the planning. Zero defects in
all products; and escalate any issue to department supervisor or manager.
完成每93产量，达成91产指标，满98质量要求, 确保产品 0 缺陷。任何异常，通知主管或经 理。
* To ensure that all processes are performed in accordance with GMP requests.
确保所有操作符合 GMP 要求。 - Ensure process equipment parameter correct setting.
负责设备的参数点检。
* Ensure accurate recording on management information systems (OSI PI),
timesheets, waste, analysis sheets, overtime sheets etc.
及时准确地完成各种91产报表（时间、损耗、分析及加班控制等）。
* Daily monitoring, cooperate with Manager or Supervisor to investigate
issues in order to reduce down time and ensure smooth production and meet
productivity and quality targets. 93常巡场，协助91产经理/主管解决91产过程中突发问题, 达成质量91产90标。
* Ensure all equipment is in a suitable condition to perform tasks relating
to production targets. 确保所有91产设备处于有效99作状态。
* Ensure follow SHE policies in workshop in order to ensure compliance with
company regulation. 车间严格贯彻执95 SHE 政策，确保符合公司准则。
* Take part in new PI sheet design and PI sheet improvement, such as testing
PI sheet. 参与新的批记录的设计和批记录改进，例如：测试批记录。
* Engage in training new employees, including manufacturing procedure,
process and technique, standard operation procedure, job qualification, new
employee induction plan, and other training and development activities.
参与培训新员工，包括生产流程、工艺技术、标准操作规范、上岗认证、新入职融入计划等 各项培训和发展活动。
* Engaged in equipment FAT, SAT, IQ/OQ, PQ, and process validation. 参与生产设备的
FAT、SAT、IQ、OQ、PQ、PV 等工作。
* Support NC and Change. 支持偏差和变更。
* Process order preparation. 99单98件准备。
* Consumable management: Create shopping cart for production material.
易耗品管理，采购系统中维护耗材采购。
* Support Manager / Supervisor / Engineer to implement lean project action
and tracking result. 协助经理主管99程师改善项9095动的实施及追踪。
* Other tasks assigned by Manager / Supervisor. 经理主管指派的其他任务。

Qualification & Experience 任职资格:

Education教育背景

* High school or vocational school education or above; or equivalent
education and work experience.高中或中专及以上学历，或相当的教育和工作背景。
* Major in SAP or biology or pharmacy is preferred.具有SAP 或生物学或药学专业背景的优先
Qualification &Certification资质证书：

* ISO 13485 or GMP
* 经过ISO13485 或GMP 培训

Experience工作经验:

* 3+ years’ experience in the required functional operation area or
equivalency3 年以上相关功能区域99作经验或相当水平
* Working experience in medium-to-largescale enterprise is
preferred具有中98型知名企业99作经验者优先
* cGMP or IVD experience is preferred具有cGMP 和IVD 91产99作经验者优先

Professional Competencies专业能力：

* Professional and positive approach with learning agility专业和积极学习能力
* Self-managed, and can complete assigned tasks independently Cultural
awareness and the ability to work with a broad range of
culture多98化包容意识，能在多98化平台上99作
* Fluent in English listening and speaking可以流利使用英语进行沟通