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Job Function
Supply Chain Manufacturing
Job Sub Function
Manufacturing Pharmaceutical Process Operations
Job Category
People Leader
All Job Posting Locations:
Xian, Shaanxi, China
Job Description
岗位名称 Position Title
生产运营支持经理 BU Support Manager
主要职责principal Responsibilities
监督管理生产服务供应商,确保合同方严格执行SOPs 并符合相关法规要求。确保生产模具、器具、零部件的清洗和生产现场环境清洁符合GMP 要求;
Supervise the service suppliers, and make sure that contractors strictly execute SOPs and in fully compliance with relevant regulations. Make sure that cleaning of production molding, utensils, parts and GMP area's environment cleaning in full compliance with the requirement of GMP;
负责生产运营支持相关MBR 和程序文件的起草/升版、验证文件审核以及质量事件调查、变更管理、CAPA 追踪等工作;
Be responsible for creation and update of MBR and procedure documents, validation documents review. And management of QI investigation, Change Control and CAPAs tracking related to Operations, etc.
负责制造和包装的批记录的审核工作,总结并提供培训改进批记录质量。
Be responsible for reviewing batch production record of formulation and packaging. Summarize errors and providing the training to improve BPR quality.
组织生产运营的周巡检。制定生产运营预算并跟踪执行情况;负责汇总报告生产运营周报;生产运营的考勤及行政事务。
Organize weekly operation Gemba Walk; According to departmental business requirements,
participate in planning the budget along with Operations lead and supervise the execution of budget; Summarize and report the weekly report of operations. Attendance and events of administration of operation
跟进培训计划,持续改进员工工作效率和技能,制订并实施关键岗位和高潜质人才培训及发展计划;
Follow up the training plan and improve work efficiency and skills of employees. Develop the program for key position and high potential talents.
支持峰季生产
To support the peak season production.
60%
组织领导 ORGANIZATIONAL LEADERSHIP
负责遵照JSC 业务目标,根据工厂和生产运营部的优先级来管理团队(包括预算,资源);负责工厂战略和变革的推动和贯彻执行。
Accountable for managing team in accordance to Site and Operations priorities following the JSC Business Cascade (Budgeting, Resources); lead the cascade and execution of site strategy and change.
结合服务型领导力的指导原则,推动以信条为本的企业文化,推进DEI 文化的实施。
Drives a Credo and DEI -based culture aligned around our guiding principles of servant leadership,
确保所有生产运营活动符合EHS 和GMP 要求,监控并持续改进生产运营部的KPI 指标;
Ensure all production operation activities in compliance with the requirement of EHS and GMP. Monitoring and continuous improvement of Operations' KPIs;
负责培养并扩展部门人员具备符合新业务新技术要求的能力
Responsible for developing team capability required from new business and new technology
制定并持续改善部门的员工培训目标,确定部门关键岗位和高潜质员工,保证接班人计划的实施完成;
Set and continuously improve the departmental employees training objectives, find key positions and hi-Pos, ensure the implementation and completion of the succession plan;
人员培训管理,确保员工完成其岗位胜任力所需的岗位资质培训和相关在岗培训, 打造高绩效,灵活的生产团队。
Manages training to ensure employees finish the necessary job qualification training and on-job training to meet competency requirements for the assigned work. Develop a flexible and high performing organization
40%
知识技能要求knowledge Skill And Ability Requirements
教育和证书EDUCATION & CERTIFICATIONS:
- 专业知识Specific knowledge
对于EHS 相关法规的了解。Understanding of Health, Safety and Environmental related regulations.
对于法规符合性的了解 (适用于制药产业GMP 和其他法规和指南,J&J 内部要求&指导方针)。
Understanding of compliance requirements (cGMP and other legislation / guidelines applicable to the pharmaceutical industry, internal J&J requirements & guidelines)
熟悉制剂产品,制造和包装工艺,生产设备,JJPS 生产系统知识以及质量控制知识。
Familiar with the knowledges of pharmaceutical product, formulation and packaging process, production equipment, JJPS production systems, and quality control.
熟悉流程优化(六西格玛),精益生产的概念和工具 Process excellence (6sigma), lean concepts and tools, and others.
商业头脑与财务知识(预算和花费) Business acumen, financials (budgeting & costing)
- 个人(领导力)技能Personal and interpersonal skills / Leadership skills
领导跨部门团队的能力Ability to lead cross functional team
应对复杂事物,管理变革的能力Ability to manage complexity and change
有能力在不同等级组织间相互沟通和影响Ability to interact at different levels of the organization.
有能力在压力下工作,处理利益冲突,做出决定 Ability to work under pressure, handle conflicting interests, make decisions
有能力在大方向下独立工作,对任务的优先级有清晰的认识,能按计划管理时间
Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
有能力创造一个以结果为导向的团队Ability to create a result-oriented team
关注于客户和业务Focus on costumer and business
诚实正直Integrity
关注于客户和业务Focus on costumer and business
有良好的团队精神Team player
协作与团队合作 Collaboration and teaming
有组织和人才发展的能力 Organization & talent development
具备进行内/外部良好沟通的能力Good internal & external communication skills
- 个人态度和心态Personal attitude and mindset
以创新和改变为驱动,保证竞争力 Drives for innovation and change to ensure competitiveness
乐观进取的心态,能够在拔高的目标和时限要求下敏捷,灵活性工作
Can-do mentality, agility & flexibility able to work with stretched goals and deadlines
愿意将团队的目标放在第一位并与团队其他人一起朝着目标努力
Willing to place the goals of the team first and work with others towards these goals
能沟通,有动力,能谈判,有自信,对他人有影响力的人
Communicative / Motivator / Negotiator / assertive person having impact
对相关专业活动有高度责任感 Showing a high sense of responsibility regarding professional activities
能应对市场、认证、供应商等的变化。Ability to deal with changes from market, compliance, suppliers, and others.
- 良好的生产规范Good Manufacturing Practices (GMP)
坚持遵守GMP 的程序 Adhere to applicable cGMP's and procedures (role model)
报告事故和偏差 Report incidents and deviations
提出改善符合GMP的解决方案 Propose solution to improve compliance with cGMP's
- 安全,健康和环境绩效Safety, Health and Environment Performance
坚持遵守EHS的程序 Adhere to applicable EH&S and procedures (role model)
报告事故,偏差 Reporting of (near) accidents, incidents, deviations
配合和建议方案提高EHS 程序 Cooperate on and suggest solutions to improve EH&S
积极促进EHS 活动,支持活动或项目例如"安全行为"
Actively promote EH&S, support campaigns/programs such as "Safe Behavior'
当看到违反EHS 规则的行为要及时制止,做出适当的行动。
Act when violation of EH&S rules is observed and stimulate appropriate behavior
相关经验related Experience
5 年以上医疗行业工作经验,3 年以上跨国公司工作经验。
5 years working experiences in pharmaceutical industry, more than 3 years working experiences in MNC.
学位degree
制药、化工、工业工程或其他相关专业本科及以上学历
Bachelor's degree in Pharmaceutical, Chemical engineering, Industrial engineering, or other related majors.
语言languages
能用中文流利的书写和交流 Fluent in written and spoken Local Language
精通英语的书写和交流 Fluent in written and spoken English (ideal not a must)
专业系统specific Systems
- 生产工艺、维修管理、目标与计划管理、PE、验证、SAP 系统等方面的知识的掌握
Knowledge of product process, maintenance management, objectives and plan management, PE, validation, SAP system.
- 文件管理系统Document mgmt. systems such as Tru Vault.
- 网络培训系统Web training / Compliance Wire
- Office 办公应用软件MS Office applications
- 熟悉GMP,熟悉生产和质量控制流程,了解生产设备、生产管理、质量管理及人力资源管理。
Good knowledge on GMPs, be familiar with production equipment, production processes, quality control processes.
Knowledge of production management, quality management, people management