生产主管Supervisor, Manufacturing product and packaging operations

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Manufacturing Job Sub Function: Manufacturing Product & Packaging Operations Job Category: People Leader All Job Posting Locations: Xian, Shaanxi, China Job Description: 主要职责PRINCIPAL RESPONSIBILITIES: 生产管理Production Management • 确保生产过程中操作人员严格按照GMP及系统指示或批记录要求完成操作与确认，确保操作人员 对批记录执行的完整性及正确性。对于生产过程中出现的异常进行系统处理和确认；完成批记录审 核； Ensure that operators strictly follow GMP and system instructions or batch record requirements to complete operations and verification during the production process, and ensure the completeness and correctness of operators' execution of batch records. Handle and confirm exception that occur during the production process; Complete batch record review; • 参加每日的生产会议（tier 1），提出存在的风险和问题，为问题的解决提供方案； Participate in daily production meeting (Tier 1 meeting), signal risks and issues, provide overview for problem solving, participate in shift handover meeting; • 配合实施相关产品、设备的验证，及时发现并协调处理生产(批记录)和验证(草案)等流程中的缺陷， 协调新产品、新工艺的试生产和试机； Cooperate with the implementation of related products, the validation of equipment, timely discover and coordinate process production (batch records) and verify (draft), and other defects in the process, coordination of new products, new process of the trial production and trial; • 及时监控和记录潜在的产品质量问题，与相关部门合作在其相应的生产设备及线上进行持续的改 进； Observe and record potential product quality issues in a timely manner and coordinate with other related team members to carry out Continuous Improvement initiatives on his / her equipment and/or line; • 根据部门的目标，利用系统化工具对生产工艺过程和数据进行分析，提供有效改进方案，降低成 本，提高生产效率及产品收率； According to departmental production goals, analyze production processes and data with PE tools, make effective improvement plan to reduce cost, improve production efficiency and product yield. • 与相关部门协调，保证生产计划平稳的进行，核心的KPI与设定的期望值一致（例如：计划达成， 及时交付，不符合事件的数量控制等）；积极参与所负责的业务团队基于客户的KPI 的达成。 Co-ordinate with the relative Departments to ensure the production plan being carried out smoothly and critical KPIs are met according to the set expectations (e.g. schedule attainment, on-time-delivery, number of non-compliance events, etc.) , proactively participate in the achievement of customized KPI. • 参与部门预算，负责已批准程序的执行；协调并实施车间新产品、新设备、新工艺、改进项目及相 关的验证；Participate in compiling the departmental budget, implement approved production procedures. Coordinate and organize the application of new product, equipment, technology, improvement projects and related validation within department; • 根据车间要求起草负责区域相关的WI 和SOP； Support in the compile of WI&SOP related to his / her responsible area; • 严格执行WI和SOP, 确保车间操作人员及环境符合GMP和EHS规范要求；保持生产设备和生产 现场的整洁，达到“5S”等的要求；实施审计改进方案； Strictly follow with WI and SOP, make sure all operators and the environment comply with the requirements of GMP, EHS; keep production equipment and the site clean and tidy to meet with "5S" etc. Implement the improvement plan recommended by audit; • 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人员，履行以下主要职责中的一项或多项： Perform one or more of the following duties as a member of the control substance safety management organization: 1. 组织制订安全管理文件，并指导、监督文件的执行。Organize the formulation of safety management documents, and guide and supervise the implementation of documents. 2. 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. 3. 负责对供应商和购买方的合法资质以及供应商销售人员、购买方采购人员的身份证明进行审 核。Responsible for reviewing the legal qualifications of suppliers and buyers, as well as the identity certificates of suppliers' sales staff and buyers' purchasing staff . 4. 对安全管理人员和直接接触特殊药品人员进行资质审核，签订安全管理责任书或岗位职责确 认文件。 Conduct qualification for safety management personnel and personnel in direct contact with control substances, and sign safety management responsibility letters or job description. 5. 组织开展安全管理教育和培训。 Organize safety management education and training 6. 负责对运输单位的资质和安全管理能力进行审核。 Responsible for reviewing the qualifications and safety management capabilities of transportation units. 7. 负责管理监控系统和报警装置，定期组织检查，保证正常运行。 Responsible for the management of monitoring system and alarm device, organize regular inspection to ensure normal operation. 8. 负责指导设定计算机化系统安全管理功能。 Responsible for guiding the setting of computerized system security management functions. 9. 负责对安全管理情况进行回顾分析。 Responsible for review and analysis of safety management. 10. 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. 11. 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. 组织领导ORGANIZATIONAL LEADERSHIP • 组织安排生产人员依据生产计划及时完成生产任务，确保产品的质量和产量，确保设备、人员的充 分利用, 协调相关部门及时解决生产中出现的问题并上报生产经理； Organize, implement production plan, ensure the production be fulfilled with right quantity and good quality in time. Be responsible for the efficient utilization of equipment & labors. Solve the problems rapidly during the production, coordinating the relevant departments if necessary, and report to production Manager; • 监控生产区域各班次操作人员对原辅料、半成品操作的准确性和及时性，并对人员提供相应的指导 Monitor each shift operator of the production area for semi-finished products, packaging materials accounting process accurately and timely, and provide corresponding guidance for personnel; • 参与部门的人员业绩考评，组织车间员工的培训，制定并实施员工培训方案，保证关键生产岗位人员 的人才储备； Participate in the employees’ performance appraisal as well as organize the relevant training. Establish and implement training and succession plan for key positions and talents; • 领导‘改善’和标准化项目，协助业务经理带领班组推动基于客户为中心的改进项目，分享最佳实践方 法，鉴定和分享改进机会，加入操作精益讨论和黄带、绿带培训并采取行动； 50% Lead Kaizen and standardization projects, support production BU manager to lead team for execution of customer oriented improvement, share best practices, identify and share improvement opportunities, join Operator Lean Forum as well as Yellow Belt/ Green Belt trainings and take actions; • 与其他部门的员工和主管建立有效的沟通； Establish effective communication with other Value Stream Team members and Shift Supervisor . 知识技能要求KNOWLEDGE SKILL AND ABILITY REQUIREMENTS: 教育和证书EDUCATION & CERTIFICATIONS 1. 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 ▪ 具备关于制造车间制剂生产，运行，操作技术，生产设备，生产系统知识以及质量控制知识的了解 Knowledge of pharmaceutical production, 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) 2. 个人（领导力）技能Personal and interpersonal skills / Leadership skills ▪ 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