Job title 职位名称: Production Process Specialist 生产专员
Location工作地点:杭州
% Remote working and % of travel expected 远程办公和出差的概率:10%
Job type工作类型: Full time全职,
Site/Unit 区域/事业部:M&S
Solid Line Manager(Job Title and Name) :生产经理Production Manager
Job description valid from:
Co-operating supervisor to solve the technical issues'and support to organize and manage the production area. Drafts the SOPs, Batch records as well as other documents related to the production. Implements LEAN & optimization projects of production. Implements production area, arrangement of operators and records daily check. 配合生产主管对生产区域进行日常的技术及管理工作'起草相应SOP,批记录及相关的生产文件'实施生产部的精益及其他优化项目'进行现场的文件记录的日常审核'以及人员的日常安排。
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Pay a close attention to daily production, make root-cause analysis for the deviation of any technical issues arose in production.
Support to routine shopfloor's supervising activities like weekly shift arrangement for operators, special production materials requirement communication, equipment status (breakdowns, urgent maintenance, pre-maintenance etc) monitoring, daily +QDCI meeting organizing, SOP implementation compliance in shopfloor, shopfloor's supervising by 3-shift turns etc.
+QDCI会议组织'现场SOP执行符合性及现场3班倒轮流值班等 。
Take part in deviations, OOS, complaints investigation with other department and follow up CAPA.
参与偏差,OOS,OOT和投诉的调查'并落实整改措施；
Process improvement and Support process validation
By optimizing the process through parameter perfecting, mechanical adjustment of machine and etc., to increase the quality and have been better output. Plan and Implement the process validation to guarantee the quality stability of the changed process.
优化设备以及工艺参数'提高产品质量。制订和实施制作区工艺验证'确保工艺改变后产品质量稳定性。
GMP and safety responsibility
Support supervisor and manager to implement cGMP in order to guarantee the quality of products and performance according to Sanofi global requirement. By reinforcing and monitoring obedience to national and Sanofi global regulation or policy, take care of safe operation protection in daily work.
As project leader to be responsible for LEAN projects, cross-department projects, make plan of projects and execute the project.
Write/update the batch records, SOPs, production records, check the completed records.
编写/升级批记录'SOP'生产记录'审核完成的批记录
Take responsibility of change control, equipment/cleaning validation, including process validation.
负责生产区域变更'设备/清洗的验证以及工艺验证。
Conduct other assigned works.
Be responsible for Quality and Health-Safety-Environment in my position/workstation.
The designated Primary Process Owner (PPO) is responsible for the assigned Quality Maturity Index (QMI)/Quality System Standard. PPO负责指定的质量成熟度指数(QMI)及质量体系标准。
PPO is responsible for assessing quality processes, review assessment and making remediation actions with the Site Leadership Team;
PPO负责质量流程评估'与工厂管理层一起审核评估结果并制定所需的改进措施；
The aim is to drive self-awareness of the quality process and drive the improvement of the maturity of the respective quality system.致力于提高对质量流程的自我认知力'并从而推动相关质量体系的成熟度的持续提升。
About you 任职资格:
List here ideally the must-haves criteria to be successful on the role.
请列出胜任该职位所必须具备的条件。
Experience:
工作经验: More than 2 years production frontline work experience or quality management in Pharmaceutical company, especially in foreign enterprise work experience (在药厂超过2年的生产一线生产或质量管理相关的工作经验'特别是在外企的工作经验)
Soft skill:
通用技能: Good communication skill良好沟通能力,learning agility快速的学习能力
Technical skill:
专业技能: Familiar to office software(熟练应用办公电脑软件), Familiar with Pharmaceutical manufacture process and shopfloor operation(熟练掌握药品生产工艺以及现场操作和管理)
语言要求: Good at English reading, writing, listening and speaking(良好的英语听,说,读,写能力)
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
Pursue progress, discover extraordinary进无止境'探索菲凡
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