Environment Monitor Expert 环境监控专家 25-45k
北京-大兴区 5-10年 本科
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绩效奖金 五险一金 交通补助 通讯津贴 管理规范 岗位晋升 带薪年假 子女福利 定期体检
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孔女士 2小时前在线 已认证
人力资源主管 · 赛诺菲
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职位介绍
  • 医药质量管理
  • 微生物研究
  • 生物药
  • 制药企业
职责描述: 1. Established environment monitor management systems in compliance with regulations (EU, cGMP, USP, ISO and CFR). 2. Introduce new technology and concept of sterility and contamination control to site in process design, qualification and commissioning of new manufacturing areas, sterile filling, aseptic processing validation, contamination risk management, quality and compliance, sterilization and sterility testing, environmental monitoring, water system design and monitoring, contamination control strategic planning. 3. Provided guidance for commissioning and qualification of a new injectable production suite and ensure collaboration and commitment among multiple groups (QA, Facilities, Manufacturing, Validation, Engineering, Process Development, Bio-Safety, and Project Management) and ensure the successful new launch. 4. Developing microbial assessment SOP and template/tools to support routine operation, eg. EM and utility monitoring and batch release testing. Determine remediation plan to keep continuous improvement. 5. Actively involved in system design decision making and team meetings – insures systems are simple, sustainable, robust, and compliant 6. Trouble shooting on issues of process, labs and utility relating to quality, compliance, contamination control. 7. Provide expertise and recommend policies, procedures, and activities ensuring that robust monitoring and contamination control programs are in place including gowning, cleaning and disinfection, environmental and critical utility monitoring, environmental controls and product protections are in place throughout the facility. 8. Accomplish in recommending policies, procedures, and activities ensuring industry best practice in cleaning and disinfection, gowning, and environmental controls are in place throughout the facility 9. Assist site quality operation regarding a. Contamination control operations and implementation of quality systems (e.g. lab investigation, OOS/OOT, deviation, CAPAs, QRM programs) as they pertain to QC, Microbiology and quality control programs. b. Process validation, commissioning and qualification of new manufacturing areas, WFI system qualification, risk assessment, environmental control (quality/facility critical alarms), environmental qualifications and engineering needs. c. Improve the trending monitoring and prompt statistical analysis on microbiological data to insure early notification of microbiological issues. d. The oversight of microbiology lab operations including processing of sampling, testing, recording, data review, lab investigations and periodical data trending, excursions analysis and reporting. e. Oversight and support for process, equipment and clean room validations including EM performance qualification, sterile gowning certification, media fill/challenge, and validations of autoclave, cartridge/Stopper/Cap washer, part washer etc.). f. Advise in the development, and critically review equipment, process, utility/system and cleaning validation plans / protocols. Validation of methods and development of procedures and protocols, setting criteria and specifications for products regarding the sterile and contamination control. g. Reviewed/comment IQ, OQ and PQ and any studies documentation. Review technical reports, qualifications, validation reports, and EM/Utility trend data, identify and implement CAPA to eliminate the reoccurrence of unexpected quality events. 10. Serve as technical expert during internal and external audits, HA regulatory inspections. 11. Provide technical guidance, professional development, and supervision the trainee growth. Contribute in contamination control and microbiology knowledge management via establishment of training material/format, delivering training course and coach the trainees. 12. Deliver training course internally and externally on contamination control of manufacturing process and environmental assurance relate to microbial awareness, aseptic technique, biosafety and environmental controls. 13. Implement GAP analysis for global requirement and local authority standard and take CAPA action 14. Manage the project related to contamination control and sterility assurance at site. Coordinate cross-function activity, making sure the implementation and deployment. 15. Own the sterility and contamination control relevant KPIs and continue the improvement. 16. Any other business and task responsibilities assigned. 任职要求: Education / Experience A degree in Chemistry, Pharmacy and Biology or other related disciplines and a minimum of 7 years’ experience in environment monitor for sterile manufacturing process. 化学、药学,生物,微生物或相关专业学士及以上学位,至少7年以上无菌工艺环境监控相关工作。 Technical skills & Competencies / Language Must be problem solving oriented. Good English writing and spoken as well as a good knowledge of Chinese and international GMP are required. 须具备善于解决问题的能力和主动性。英语说、写良好。要求了解中国和国际GMP要求。 Behavioral competencies (lead and others) Inspires continuous improvement & breakthrough thinking, display analytical &conceptual thinking. 鼓励持续性改进和突破性思维,展示分析性和概念性思维能力,展示分析性和概念性思维能力 Good communication 良好的沟通能力 Able to burden pressure, result driven 能够耐受压力,结果导向。
其他信息
语言要求:不限
行业要求:制药

公司简介

赛诺菲集团是一家全球领先的多元化的医药健康企业, 致力于研究、开发、生产并销售医药健康产品 全球领先的多元化医药健康企业 超过110,000名员工遍及100多个国家 多元化产品,包括药品、疫苗及创新治疗方案 2012年净销售额达349亿欧元 在40个国家设有112家工厂 赛诺菲集团是一家全球领先的多元化医药健康企业,专注于患者需求。 赛诺菲的业务覆盖处方药、疫苗、健康药业、罕见病和动物保健品,拥有超过11万余名员工、遍及100多个国家。 赛诺菲巴斯德是全球疫苗领域的领导者。每年可生产10亿剂疫苗,可预防20种疾病,使全球超过5亿人获得免疫保护。 集团可持续发展的七大核心增长平台分别是新兴市场、糖尿病综合管理、人用疫苗、健康药业、动物保健、健赞(罕见病)以及创新产品。2012年,集团净销售额达349亿欧元。在新兴市场,赛诺菲表现强劲,是2012年新兴市场排名第一的医药健康企业。 作为可持发展的增长平台之一,集团研发部致力于为患者加速创新,目前,64种药品和疫苗正在临床开发阶段,其中有18种药品有望在2012至2015年间上市。 赛诺菲将企业社会责任融入企业的核心价值观和可持续发展战略。 赛诺菲的企业社会责任理念和履责绩效得到了众多机构的认可(包括评级机构、非政府组织、研究机构和大学等)。2012年,赛诺菲再度跻身全球多个权威的企业社会责任指数。
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