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**Job Function: **
Supply Chain Manufacturing
**Job Sub Function: **
Plant Management
Job Category:
People Leader
All Job Posting Locations:
Xian, Shaanxi, China
Job Description:
主要职责PRINCIPAL RESPONSIBILITIES:
- 管理产品生产流程，以具有竞争力的成本, 在合理的时间内生产出高质量的产品来满足市场需求，同时保持良好的审计预备状态和法规的符合性，适应供应链的变化，满足销售需求
- The position holder shall manage the Xian site operation processes and supply high quality products at the right time with competitive cost to meet customer requirements; maintain audit readiness and comply with standards set by regulatory bodies; adapt to the changing requirements of the supply chain to meet the demands.
- 生产运营部负责人需向工厂总经理直线报告，并领导各自所辖的生产运营团队（包括经理和主管）。 生产运营部负责人负责日常生产管理和相关成本改进项目的实施
- The operation lead will report solid line to plant general manager and lead a team of manager and Supervisors in own responsible area. Operation lead will be responsible for day-to-day Production Management as well as related CIP Project execution.
- 承担企业生产管理负责人的职责，全面负责企业日常生产管理。确保生产实现质量目标并按照GMP规范要求生产药品
- Take the responsibility of the head of production management for the overall daily production management of the enterprise. To ensure to achieve the quality objective and compliance with GMP in the operation.
- 当自身不便时可以将相关GXP活动授权给具有适当资格、经验和培训的委托人，具体委托流程可参考TV-SOP-47067杨森制药西安工厂授权管理程序。
- The relevant GXP activities could be delegated to the designees with appropriate qualifications, experience and training when unavailable, for delegated process could refer to the requirements of TV-SOP-47067 XJP Delegation of Authority SOP.
生产管理Production Management for the Site
- 制定生产部门的业务目标和KPI指标并定期对达成结果进行管理。协调并执行生产计划，安排有效的柔性生产，确保提供高质量的产品，保证生产活动在法律/法规要求上的合规
- Set up goal and KPIs target for production department and manage and monitor the achievements. Coordinate & implement production schedule with flexibility and ensure product quality to meet with relevant specifications. Ensure the operation compliant with all the legal/regulatory requirements.
- 确保所有操作符合环保、安全和工业卫生法规，满足J&J 的相关要求；完成MAARS MAPs；
- Ensure all operations is complied with environmental, safety, industry hygiene regulations and J&J requirements. Complete MAARS MAPs;
- 制定并实施部门环保、安全和工业卫生方面的工作目标，为员工提供安全舒适的工作环境；确保所有生产员工被培训到相关的EHS流程及方针;负责管理和识别生产相关的环境/健康/安全风险和影响
- Establish department environmental, safety and industry hygiene objectives, provide safe & comfortable working environment. Ensure all production associates are trained with required EHS procedures and policies. Responsible for the management of EHS risks associated with the manufacturing operation and the introduction of new product and process
- 具有强烈的质量管理意识，在生产过程中严格贯彻执行GMP相关法规及程序的规定；确保GMP MAPs 按照计划完成；通过改进项目的实施持续改进生产流程；促进发扬以质量为中心的文化，确保GMP规范的符合性
- Make sure all cGMP related regulations and procedures are strictly performed with strong sense of quality control in production processes. Ensure GMP MAPs are completed as planned. Continuously improve manufacturing processes by implementing improvement projects. Promote a quality-focused culture to ensure all the GMP requirements are adhered to
- 确保所有意外事件和不符合项被及时调查，整改措施按期完成
- Ensure all accidents, incidents, non conformance are thoroughly investigated and corrective actions are completed on schedule
- 确定和协调部门的成本节约项目（包括不限于提高劳动生产率，减少浪费，降低费用，积极鼓励和促进创新方案的实施。制定并管理生产预算，实现生产部门的财务目标如人力资源管理控制、成本节约及CAPEX 项目的完成
- Identify and implement cost improvement projects including but not limit to labor productivity improvement, waste control, spending reduction，actively encourage and promote implementation of innovative solutions . Develop & manage the departmental budget, achieve production financial commitment such as resource control, cost reduction and CAPEX projects.
- 与计划部门合作根据客户需求的变化，安排生产优先级，按时交付产品Cooperate with planning to prioritize the production resource, manage variations of demand to fulfill customer requirements
- 支持相关部门完成新产品试制、新工艺、新材料及新设备的验证工作Supports related dept. to complete the trial of new products, materials, equipment/ facilities and the validation of new processes.
- 确保日常操作符合特殊药品安全管理制度及相关文件要求。Ensure that daily operations comply with control substance safety management system and related document requirements.
- 作为特殊药品安全管理机构生产管理负责人，履行以下主要职责：Perform the following duties as the person in charge of production management of the control substance safety management organization:
- 依据特药管理法规制订并批准安全管理文件，并指导、监督文件的执行。
- Approve issued safety management documents in accordance with control substance management regulations, and guide and supervise the implementation of these procedures.
- 负责指导并监督特殊药品生产全过程的安全管理工作。
- Responsible for guiding and supervising the safety management of the whole process of production of control substance.
- 对安全管理人员和直接接触特殊药品人员进行资质审核，签订岗位职责确认文件。
- Conduct qualification for safety management personnel and personnel in direct contact with control substances, and sign job description.
- 组织开展安全管理教育和培训。
- Organize safety management education and training.
- 确保成品发货前负责对运输单位的资质和安全管理能力进行审核。
- Ensure check the qualifications and safety management capabilities of transportation units before FG shipping out.
- 负责对监控系统和报警装置定期组织检查，保证正常运行。
- Responsible for the usage of CCTV and alarm device, organize regular inspection to ensure normal operation.
- 负责对安全管理情况进行回顾分析。
- Responsible for review and analysis of safety management.
- 负责异常情况和安全事件的调查、处理及报告。
- Responsible for the investigation, handling and reporting of anomalies and security incidents.
- 负责生产运营所属精麻区域外来人员陪同及保安监督工作。
- Responsible for the escort and security supervision of external personnel in the control substance area under operation.
- 组织实施安全管理体系的自检，并对安全风险管理措施的有效性进行评估。
- Organize the implementation of safety management system self-inspection and evaluate the effectiveness of safety risk management measures.
企业生产管理负责人 The head of production management for the Site
- 确保药品按照批准的工艺规程生产、贮存，以保证药品质量To ensure that products are produced and stored according to approved master manufacturing documents in order to obtain the required quality
- 确保严格执行与生产操作相关的各种操作规程To ensure strict implementation of the procedures relating to production operations
- 确保批生产记录和批包装记录经过指定人员审核并送交质量管理部门To ensure that the batch records of processing and packaging are evaluated and signed by a designated person before they are sent to the quality management department
- 确保厂房和设备的维护保养，以保持其良好的运行状态To ensure that the premises and equipment are maintained and serviced to function in a sound operating state
- 确保完成各种必要的验证工作To ensure that the necessary validations are done
- 确保生产相关人员经过必要的上岗前培训和继续培训，并根据实际需要调整培训内容To ensure that required initial and continuing training of personnel in production is carried out and adapted according to need
组织领导ORGANIZATIONAL LEADERSHIP
- 发展建立团队和个人的可量化的目标，衡量实际绩效的达成，并且提供及时而诚实的绩效反馈Develop both team and individual goals and objectives, measure the actual performance against them, provide timely and honest feedback on performance
- 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，创新无限，至于至善。崇尚创新，敬业，协同和发展Drives a Credo-based culture aligned around our guiding principles of servant leadership, Think Differently, Do Better, innovation, engagement, collaboration and development;
- 管理和激励发展下属，使其能够运用重要领导力行为提高绩效Manage, motivate and develop production staff in line with the vital behaviors to improve their performance
- 结合业务发展的需要，实施生产团队能力的培养，结合OTI等培训项目推动的生产部门的灵活性和敏捷性。培养部门关键岗位和高潜质员工，保证接班人计划的实施Develop the capabilities of production team based on business needs leveraging the OTI program to improve production flexibility and agility。Develop talents and Hi-Po, implement and complete the succession plan
- 培养提升生产人员按照价值流管理生产的能力，推动value stream team 在生产区域的改进项目实施Develop the capability of production team to facilitate and enable the improvement execution driven by value stream team
- 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Manages training to ensure employees finish the necessary job qualification training and on-job training to meet competency requirements for the assigned work
- 负责生产人员的日常管理，包括人员招聘与合同终止。为员工提供公平的发展机会，在生产部门维持以信条为中心的文化Handles all aspects of managing personnel, including hiring and terminations. Provides development opportunities to each individual and maintain Credo based culture
- 在生产部门营造及维持以客户为中心的文化氛围Foster a customer focused culture in production
**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内部要求和指导方针）Understanding of compliance requirements (cGMP and other legislation / guidelines applicable to the pharmaceutical industry, internal J&J requirements & guidelines)
- 熟悉EHS相关要求 Understanding of Health, Safety and Environmental related regulations
- 关于产品制剂生产，包装过程，操作工艺，生产设备，生产系统知识以及质量控制知识的了解Knowledge of Solids pharmaceutical production, packaging process, operation technology, production equipment and production systems, Knowledge of quality control
- 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, and take 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 (project) team.
- 关注于客户和业务Focus on costumer and business
- 诚实正直Integrity
- 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)
- 正确使用可用的个人和集体的保护用品Correct use of the available personal and collective protection materials
- 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:6 - 8 年
- 生产管理负责人应当至少具有5年以上医药行业工作经验，具有至少三年从事药品生产和质量管理的实践经验，其中至少有一年的药品生产管理经验，接受过与所生产产品相关的专业知识培训The head of production management should, 5 years working experiences in pharmaceutical industry, with at least three years of practical experience in pharmaceutical production and quality management, among which at least one year in production management, with necessary training relating to the products being manufactured.
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；作为生产管理负责人应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格）Bachelor degree in Pharmaceutical, Chemistry engineer, Industrial engineer or other related majors；The head of production management should, at a minimum, possess a college degree in pharmaceutical or relevant specialties (or with an intermediate professional technique certificate or a pharmacist’s license).
语言LANGUAGES:
- 能用中文流利的书写和交流Fluent in written and spoken Local Language (must)
- 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、SAP、自动化系统、制造执行系统（MES）等方面的知识的掌握Knowledge of production, maintenance management, objectives and plan management, PE, validation, SAP system, AIL/MES system 文件管理系统（DocSpace）Document mgmt. systems such as ERIS DocSpace 网络培训系统Web training/ Compliance wire 办公应用软件MS Office application Office 熟悉GMP，熟悉生产和质量控制流程，了解生产设备、生产管理、质量控制及人力资源管理Good knowledge on GMPs, be familiar with production equipment, production processes, quality control processes. Knowledge of production management, quality management, people management
**Required Skills: **
Preferred Skills:
Agile Manufacturing, Benchmarking, Developing Others, Good Manufacturing Practices (GMP), Inclusive Leadership, Leadership, Manufacturing Compliance, Manufacturing Safety, Organizational Project Management, Organizing, Plant Operations, Process Improvements, Strategic Supply Chain Management, Tactical Planning, Team Management