锦鲤求职岗位描述
在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。
职位
Principle Roles & Responsibilities / Accountabilities主要职责/责任
Routine Operation:
Perform the microbiological testing on the samples from incoming raw materials and packaging materials, produced bulks and products, environment monitoring, process validation and cleaning validation, etc. Issue the reliable analytical report in reasonable lead time.
Adhere to all effective SOPs and safety requirements and document laboratory work consistent with cGMP requirements
Assist Head of Microbiology lab to complete GMP Self-Inspection as well as the relevant CAPAs to maintain the global level of GMP compliance.
Presents technical analytical data clearly and concisely data to internal investigations and regulatory inspectors.
Accomplish the calibration and maintenance of assigned instruments, to ensure they are in good order to meet the analytical needs any time.
Report the abnormal status, unexpected results to supervisors with initiative.
● By reporting abnormal status and unexpected results during analysis processing by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time.
Maintain laboratory cleanliness and inventory of microbiology supplies
Supports lean initiatives in the area of lab operations, test method execution, documentation updates and equipment qualification
Engineering Project Support and Operation Readiness:
CCS Support: Support the establishment of the Contamination Control Strategy (CCS) for the aseptic production line.
Environmental Monitoring (EM): Support EMPQ execution according to the project timeline.
Microbiology Method Validation: Support the microbiology methods transfer, including supporting the confirmation of cleaning and disinfection processes, and the efficacy of disinfectants.
Equipment Support: Support the Performance Qualification (PQ) of laboratory equipment and ensure routine operation.
Qualification and Experience 能力与经验
Education/Qualifications
● Bachelor’s Degree (Life Sciences, Microbiology, or Analytical Sciences is preferred) and above
Job Required Competencies
● 2 or more years of QC experience, QC experience, with a focus on microbiology and aseptic processes. MNC Bio-pharma experience is preferred
● Sound knowledge of quality control procedures and legal standards, with experience in aseptic assurance and microbiological testing.
● Experienced in QC new facility startup readiness and operation ramp up is preferred.
● Fluent communications skills in English
● Project management skills are preferred.
我们是谁
打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。
让我们一起，构建更健康的未来。
罗氏提供平等的职业发展机会。