北京招聘

SCOPE OF THE ROLE AND BASIC PURPOSE/职位与基本目的的范围

Sterility Assurance Supervisor is responsible for end-to-end implementation of contamination control and sterility assurance policies and strategies for China and the Asia-Pacific area for Global Orthopedics and Global Surgery, and will assure that regional programs are aligned with the overall J&J Sterility Assurance programs.

无菌保证主管负责中国和亚太地区全球骨科的污染控制和无菌保证政策和战略的端到端实施，并确保区域全球骨科项目与J&J的整体无菌保证计划一致。

Responsible for sterility assurance support to NPD, validation of new products, processes and equipment in Johnson and Johnson Medical Suzhou Ltd.. Trouble-shooting non-conformances, OOS root cause analysis, design and implementation of robust corrective action plans. Supports integration of new acquisitions, assists in due diligence, gap analysis and remediation activities.

负责无菌保证支持强生苏州医疗器材有限公司的新产品开发，新产品、工艺和设备的验证。解决不合规、OOS根本原因分析、健壮的纠正措施计划的设计和实施。支持新需求的整合、协助尽职调查、差距分析和整治措施。

§ Responsible for creating and maintaining quality documentation for related equipment, processes and products to assure the expected quality in accordance with all applicable requirements. 负责创建和维护相关设备、工艺和产品的质量文件，确保预期质量满足所有适用要求。

§ In partnership with J&J sterility assurance experts and sterilization engineers, responsible for the implementation and validation of the microbial aspect for all related equipment and processes.与J&J灭菌保障专家、灭菌工程师合作，负责所有相关设备和工艺的微生物方面工作的执行和验证。

§ Carry out regular monitoring of all microbial systems in JJMSZ. 执行所有微生物体系的常规监控

§ Conduct cleaning /sterilization validations of terminally sterilized medical devices using Gamma irradiation, EO sterilization etc. 执行终端灭菌医疗器械（Gamma辐照灭菌、环氧乙烷灭菌等）的清洗/灭菌验证。

KEY RESPONSIBILITIES/TASKS (indicate estimated % of time spent where possible)/ 主要职责/任务(以时间的百分比表示)

50% - Sterility Assurance and Quality operations无菌保证与运营质量

30% - Production, manufacturing engineering, quality engineering, facility, maintenance生产、制造工程、质量工程、设备和维护

20% - Contract sterilizer, contract labs, J&J Sterility Assurance合同灭菌商、合同实验室、J&J灭菌保障

ACCOUNTABILITIES/KEY MEASURES/职责/主要衡量指标

§ Perform the principal duties of the Sterility Assurance Supervisor position:无菌保证主管主要职责：

o Management of microbiology /sterility assurance team, provide related on-the-job-training to related engineers, and make sure the engineers perform the work following Johnson &Johnson requirements and regulation requirements.管理微生物/灭菌团队，提供相关工程师工作相关的培训、确保工程师按照强生要求和法规要求执行工作。

o Understand and maintain in collaboration with all functions in all the processes related to a given group of products.与所有部门的合作，理解和维护给定产品族相关的所有工艺。

o In connection with other departments in China and Overseas, provide in-time and compliant technical support in order to meet all business objectives. 联系中国和海外的其它部门，确保技术支持的及时性和合规性，支持业务目标。

o In partnership with DePuy Synthes and Global Surgery sterility assurance team:和Depuy Synthes和Global Surgery灭菌保障团队合作：

ü Develop, implement, maintain and continuously improve the sterility assurance (microbiology and sterilization) aspects of the Quality operations.开发、实施、维护和持续的提高运营质量的灭菌保障（微生物和灭菌）方面。

ü Conduct cleaning/sterilization validations of terminally sterilized medical devices using Gamma irradiations, EO or other sterilization methods. 执行终端灭菌医疗器械（gamma辐照灭菌、环氧乙烷灭菌者其他灭菌方式）的清洗/灭菌验证工作。

ü Validate the microbial aspect of related equipment and processes. .相关设备和工艺的微生物方面验证工作。

ü Develop and implement all procedures for microbial assurance activities in accordance with all applicable requirements. 开发和执行微生物保障活动的所有程序，符合所有适用的要求。

o Carry out regular monitoring of all microbial systems (i.e. water systems, cleanliness, washers, cleanrooms…). 执行所有微生物体系的常规监控（如水系统、清洁、清洗机和洁净室）。

o Provide support for GMP training program for clean room and other appropriate staff. 提供洁净室和其他适用员工GMP培训项目的相关支持。

o Perform external audits of sterilization subcontractors, contract laboratories and contamination control related suppliers. 执行灭菌承包商、合同实验室和洁净服供应商的外部审计。

o Support R&D on new products development. 支持R&D新产品开发。

§ In accordance with JJMSZ Quality strategy, participate to the development of the quality system and its day to day implementation: 根据JJMSZ质量策略，参与质量体系开发和日常执行。

o Participate in training or workshop and deploy on site the Quality philosophy based on FDA QSRs, CFDA and other applicable regulatory requirements. 参与车间员工培训，基于FDA QSRs, ISO 13485和SFDA要求，现场部署质量理念。

o Ensures compliance to all GMPs and J&J quality policy/standard requirements. 确保符合所有GMPs和强生质量政策及标准要求。

o Conduct internal and supplier quality audits at a Lead Auditor level as required. 按要求，在主审层级上，执行内部和供应商质量审计。

§ Perform all job duties in full accordance with:所有工作职责完全符合：

o The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information. J&J信息政策、资产保护、密码保密维护、关键业务信息保护。

o All J&J policies and local regulations. 所有J&J和当地法规要求。

o The policies of the Health Care and Environmental programs. 医疗健康政策和环境项目。

o The code of conduct policies. 行为准则。

§ Full responsibility and ownership for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…).对所有审计（内审、合作、外审、对质量、H&S、环境等），负全责和所有权（比如所有员工在现场）

§ Performing other related duties as assigned by management.执行管理层分配的其它相关工作。

POSITION DIMENSIONS/职位简述 Level of Supervision Required/需要被管理的层次: Level/层次 X Direct Supervision: Will be issued detailed instructions to carry out work. All questions and problems are referred to supervisor 直接管理：将在具体的指导下工作。所有问题须请示主管。 Close Supervision: Consults on established procedures to carry out work. Able to respond to routine problems independently 紧密管理：经指导建立流程以开展工作。能独立地回应日常工作中的问题。 Limited Supervision: Determines own methods to accomplish work. Able to respond independently to majority of complex problems on own 有限管理：自行决定方法以完成任务。能独立地回应绝大多数复杂的问题。 x No Supervision: Work is self-initiated. Anticipates and resolves all complex problems independently. Develops solutions that typically become new process and procedure 无须管理：自发开展工作。预见并独立解决所有复杂问题。发展解决方案以成为新的流程。

强生是全球具综合性、业务分布范围广的医疗保健企业，业务涉及消费品、制药、医疗器材三大领域，1985年在华创立了***家合资企业。强生遵循企业信条的价值观，致力于践行“关爱全世界,关注每个人”的健康愿景，以领先的科技研发创造创新的理念、产品和服务，为改善人类健康和福祉而不懈努力。每天，强生遍布世界各地的员工，与他们的合作方一起，为全球消费者和病患带来更健康、更快乐、更长寿的生活。
强生于1985年在华创立了***家合资企业。 多年来，强生不断发挥行业领军作用，以创新、高质量的产品和服务，为中国亿万家庭带来健康。如今，强生在中国的业务涉及消费品、制药、医疗器材三大领域，在北京、上海、广州、苏州、西安等90多个城市，拥有员工总数近10,000人。强生在西安高新技术产业开发区投资兴建先进的大型生产基地，以更好地服务中国和亚太地区其他国家。
强生是***在中国成功实现“端到端”研发模式的跨国企业；并通过实现从早期研发到临床应用，致力于加速中国创新产品的研发，促进中国创新型经济的发展。强生的三大业务领域在中国均设有研发机构, 并在上海建立了强生亚太创新中心，将源自于中国和亚太区域的创新成果推向国际市场。
该创新中心是强生深化外部合作战略的主要窗口。强生将密切与创新企业、学术和科研机构，以及优秀人才的合作，通过提供资金、专业知识和技术，共同将雏形创新转化为医学临床应用的成果，强生并在中国建立全球肺癌研究中心，以满足中国及国际市场的需求，造福病患。
强生心系中国的发展和进步，致力于成为优秀的企业公民。强生积极参与各类重大活动，助力中国的社会经济发展， 并荣幸的成为2008年北京奥运会及残奥会和2010年上海世博会美国馆的全球合作伙伴。
为加强对中国市场的承诺，强生于近期部署了中国发展新战略。强生将融汇全球的资源、凝聚在华的核心业务能力，更加稳健的迈开公司积极创新、完美执行和锐意领先的步伐，为中国创造更多价值。
强生多次荣获《巴伦周刊》“全球最受尊敬企业”的荣誉，充分体现了强生始终以实际行动改善人类健康福祉的不变理念。
2017年，强生连续第33年入选美国《财富》杂志发布的全球最受赞赏企业排行榜，位列总榜第13名，居全球制药行业榜首。