* 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