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Quality

Quality Control Microbiology Supervisor

  • Başlık Quality Control Microbiology Supervisor
  • İşlev Quality
  • Alt fonksiyon Quality Control
  • Konum Hangzhou, Zhejiang, China
  • Postalanan
  • İstek Kimliği 2306109647W
Hemen Başvur
Paylaş

Tarif

1.  领导并管理微生物团队进行相关微生物测试(无菌,GPT, 生物负载, 微生物限度, AME/PET测试等)。
Lead and manage the Micro team for the execution of the microbiological testing (Sterility, GPT, Bio-burden, )Microbial Limits, AME/PET testing, etc...)
2.  负责调查超限/OOS/NC 并找到根本原因;负责CAPA的发起及相应的行动项的跟进。做到及时、准确,逻辑清晰、能够提供行之有效的纠正预防措施。负责相关变更的发起、追踪与关闭。
Be responsible for the Excursion/OOS/NC investigation to find out the root cause; Be responsible for the CAPA initiation and related activities follow up. Ensure the investigation performance detailed and specific with logistic, as well as the CAPA effective. Be responsible for related Change Request initiation, tracking and closure. 
3.  负责培养基模拟灌装过程的监督检查,以及负责培养基灌装产品无菌性检查的指导和监督。
Be responsible for media fill simulation process inspection, and also be responsible for guiding and inspecting the media fill products' sterility check.  
4.  根据实验室检测需求,协助经理制定培训发展计划,并对新员工进行检验技术培训,使其实际操作技能符合GMP/EHS要求。
Assist manager to make the training plan for laboratory employees according to testing needs, perform the technical coach for new employees and make sure that the operation skills of new employees comply with GMP/EHS requirements.
5.  负责微生物实验室各项验证工作,包括仪器验证、方法验证、方法适用性确认、消毒剂验证等。
Be responsible for the validation in micro lab, such as equipment validation, method validation, method suitability verification, disinfectant validation etc.
6.  负责微生物实验室相关评估,按照规定时间完成相应的评估提出建议行动计划,如药典更新后的评估,法规更新后评估及总部程序更新后本地程序的评估等。
Be responsible for related assessment in micro lab, completed the assessment and suggest the action plans accordingly, e.g. assessment for Pharmacopoeia revision, assessment for regulation update and assessment for local procedure according to global procedure update.
7.  负责微生物实验室的卓越运营和持续改进工作;优化微生物实验室的工作流程;改善微生物实验室工作效率。
In charge of micro lab operation excellence and continuous improvement; optimize lab workflow; improve lab working efficiency.
8.  负责微生物实验室的EHS工作,严格遵循强生EHS政策,落实《安全生产法》及相关法规所要求的岗位安全责任,遵守本单位的安全生产规章制度和操作规程,正确佩戴和使用劳动防护用品,接受安全生产教育和培训,持续改进EHS工作流程,发现上报消除潜在隐患。
In charge of micro lab EHS&S management. Follow up JNJ policy of EHS strictly, as well as Production Safety Law and relevant local regulations on the post safety responsibilities. Follow up procedures and work instruction, correctly use PPE and participate training. Contribute to continuous improvement the EHS working process of QC to eliminate potential risk.
9.  遵循ISO13485,GMP,21CFRPart 820,21CFRPart 211及公司政策,符合规定的要求,协助经理进行各种审计准备。
Comply with the requirements of ISO13485, GMP, 21CFRPart 820, 21CFRPart 211 and company regulation, assist manager in audit preparation.
10.  执行其它管理职责,如部门预算建立,财务数据的统计,项目相关费用和工时的统计以及部门培训协调等
Perform other management responsibilities such as lab budget establishment, financial data statistics, project related expense & labor hours statistics and training coordinate etc.
11.  对直接汇报的下属人员履行管理职责;包括这些人员的绩效评估,人员发展,以及相关的培训、监督和指导。
Executing management responsibilities for the direct report staffs, including performance review and talent development, associated with training, monitoring, coaching for these direct report staffs.
12.  其他:执行其它工作任务,例如团队的紧急任务。

Nitelik

1. 良好的人际沟通能力,正直诚信,关注细节。
Good communication and interpersonal skills, Integrity and ethics and detail oriented.
2. 能够熟练阅读相关的英文方法和文献;并能够用英文进行交流;能够独立与国外SME和供应商进行交流和沟通。
Able to read relevant English methods and literature; Have the capability of English communication, communicate with external SME and suppliers.
3. 能够娴熟的使用Windows及Office办公软件。能够用PPT编写报告、Excel等实验室质量控制软件进行数据分析及图表化。
Computer operation skill is well, such as practice in Excel, Word and PowerPoint. Be able to use PPT to prepare reports and use Excel and other laboratory quality control software to perform data analysis and graph it.
4. 能够进行多部门沟通和协调完成任务;安排实验室工作保证正常运作,协调或组织跨部门项目开展。
Be able to communicate and coordinate with multi departments and fulfill the task; arrange lab work to ensure the normal operation and coordinate or lead cross-function project.
5. 能应用概率、统计推理等数学概念。能在有限的明确标准下,处理各种具体变化情况,解决实际问题,能将各种程序或规则说明以书面、口头、图表或计划表的形式进行阐述。能够成为相关领域的专家。
Have the ability to work with mathematical concepts such as probability and statistical inference. Have the ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists, have the ability to explain various procedures or rules in the form of written, oral, charts or schedule form. Ability to be a subject matter expert for the related area.
6.生物制药或药品无菌灌装和相关的微生物技术、方法和法规要求的基础知识;在微生物限度 、无菌、抗微生物效果和防腐剂效果测试等各领域的知识;建立和维持环境监控、水系统取样 和测试计划的知识。环境监测方案知识应包括但不限于设计、应用和在生物技术, 生物制药及医药领域的管理;传统的微生物鉴定方法和快速微生物测试方法的知识。
Knowledge of fundamentals of bio-pharmaceutical or pharmaceutical aseptic filling and associated microbiological techniques, methods and regulatory requirements. Knowledge in the areas of Microbial Limits, Sterility, Anti- Microbial effectiveness and Preservative effectiveness testing; Knowledge in establishing and maintaining an EM, Water sampling and testing program. The knowledge of environmental monitoring program should include but not limited to design, applications and management in the biotechnology, bio-pharmaceutical or pharmaceutical fields. Knowledge of traditional microbial ID methods and strong support of rapid microbial methods.

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