JD基本信息
岗位职责
Main responsibilities职责描述:
Please indicate here the main job responsibilities请列举该职位的主要工作职责。
1、 Be an expert in at least one key technical position, master the responsibilities and content of the position, and be able to coordinate the personnel of that position to plan and arrange work content, so that production is strictly carried out according to Standard Operating Procedures (SOP), process procedures, and batch record requirements efficiently.
至少是一个关键技术岗位的专家,掌握其岗位职责、内容,能够协调该岗位人员,统筹安排工作内容,使生产严格依照标准操作规程(SOP)、工艺规程、批记录要求高效完成。
2、 Master the personnel situation of at least one key position, and be able to plan the training of that position, including the selection of training personnel, the formulation of training plans, the preparation of training content, the tracking of training progress, and the assessment after training completion.
掌握至少一个关键岗位的人员情况,能够有计划的对该岗位进行人员培训,包括培训人员的筛选、培训计划的制定、培训内容的准备、培训进程的追踪和培训完成后的考核等。
3、 Regularly summarize the anomalies or frequent problems related to a certain key position and conduct workshop training for relevant employees.
定期对某一关键岗位相关的异常或频繁发生的问题进行总结,workshop培训相关员工。
4、 Review the batch records and other documents involved in the relevant positions, and be able to upgrade the batch records and update SOP documents.
审核相关岗位涉及的批记录等文件,能够进行相关批记录的升级、SOP文件的更新。
5、 Understand and be familiar with the quality system processes such as deviations and changes, and be able to participate in the investigation and analysis of deviations, and propose suggestions for corrective and preventive measures.
了解并熟悉偏差、变更等质量体系流程,能够参与偏差的调查分析,提出纠正预防措施建议。
6、 Take certain management measures to ensure that operators comply with appropriate work behaviors, attitudes, instructions, policies, etc., as stipulated in the employee handbook.
采取一定的管理措施使操作员工遵从但不限于员工手册上所规定合适的工作行为、工作态度、工作指令、政策等。
7、 Strictly obey the laws and regulations related to the safety management of psychotropic drugs.
严格遵守特殊药品安全管理有关的法律法规。
8、 Perform job operations according to the company's management procedures for psychotropic drug; report any abnormalities promptly.
按照公司的特殊药品的管理规程进行岗位操作;发现异常及时上报
9、 Attend psychotropic drug safety management training on time and pass the assessment.
按时接受特殊药品安全管理培训并通过考核。
Real-time tracker of on-site production conditions.现场生产情况的实时追踪者。
1、 Be able to master the production progress of your own working area, including shift output, batch change, production equipment operation status, production materials, production anomalies, and other information, and share timely information in the +QDCI meeting.
能够掌握自身工作区域的生产进度,包括班产量、换批情况、生产设备运行状态、生产物料情况、生产异常状况等信息,并在+QDCI会议上进行及时的信息分享。
2、 Be able to communicate and cooperate with quality, maintenance, logistics teams to solve issues related to batch records, deviations, cleaning/cleanout, personnel work behavior, equipment, materials, on-site management 5S, etc.
能够和质量、维修、物流团队交流合作,解决相关批记录、偏差、清场/清洁、人员工作行为、设备、物料、现场管理5S等方面的问题。
3、 Understand relevant KPI data targets and be able to propose reasonable and effective suggestions to improve KPIs.
了解相关KPI数据目标,能够提出合理有效的提升KPI的建议。
Participant in production projects.生产项目的参与者。
1、 Participate in or lead LEAN improvement projects within the front-line team. Participate in and complete at least one LEAN improvement project.
参与或领导一线小组内的LEAN改进项目。至少参与并完成1项LEAN改进项目。
2、 Participate in or lead production improvement projects, be familiar with the project process. Be able to understand or participate in the preparation of production validation documents, organize the front-line team to execute the project plan plannedly, track the project progress in a timely manner, and train or showcase the output results.
参与或领导生产改进项目,熟悉项目流程。能够了解或参与生产验证文件的准备工作,能够组织一线团队有计划性的执行项目计划,能够及时跟踪项目进程,并对输出成果进行培训或展示。
Assistant in production safety生产安全的协助者。
1、 Supervise and comply with GMP/HSE and Sanofi headquarters requirements to ensure the quality and safety of the products produced.
监督并遵守GMP/HSE及赛诺菲总部要求,确保生产产品的质量安全。
2、 Supervise the production area employees to wear safety protective equipment correctly, comply with safety production regulations, and ensure the safety of daily production operations.
监督生产区域员工正确佩戴安全防护用品,遵守安全生产条例,确保日常生产的操作安全。
3、 Be responsible for the quality and occupational health and safety environment work within the scope of responsibility (position).
对职责范围(岗位)内的质量和职业健康安全环境工作负责。
Actively complete other tasks assigned by superiors, departments, and the company.积极完成上级、部门和公司布置的其它工作任务。
Encourage the development of multiple skills鼓励多技能发展。
任职要求
• Experience:
工作经验: above 1 year/1年以上
• Soft skill:
通用技能: work hard and carefully, good at learning new things(工作仔细认真,善于学习新事物)
• Technical skill:
专业技能: Pharmacy or automation and related field (药学或设备自动化相关领域)
Familiar to office software(熟练应用办公电脑软件)
• Education:
教育背景: High school or secondary education高中或中专以上学历
• Languages:
语言要求: Chinese Mandarin普通话
• Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi
全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致
工作城市:
杭州,招聘1人,详细地址:滨江区江陵路325号