Senior Analyst，Biologics Lab (职位编号：34121923)社

面议

市辖区硕士及以上4年及以上

发布时间：2023-09-06

职位描述

Role & Responsibility
Implement GMP compliance with global GMP standards and China GMP requirement
By assisting manager to conduct GMP self- inspection, and following-up the implementation action to maintain the global level of GMP compliance.
By maintaining the quality system and documentation system to ensure quality system operation in QC meet the regulatory requirement.
Effectuate management of sample distribution and analytical process inspection to ensure timely releases of analytical report to support business need.
By managing working schedule of relative section, to optimize utilization of human resources.
By monitoring the analysis process to supervise the analytical report issued in reasonable lead time.
By monitoring the timely calibration and maintenance of instrument within working section, to ensure they are functional well.
By monitoring the timely entering and complementing of lab materials, including but not limit to reagent, solution, column/capillary and reference standard in working section, to ensure sufficient supply.
Assist lab manager to complete the assigned routine testing, issue the reliable analytical report in reasonable lead time.
By mastering analytical methods within working section, complying with professional morality and etiquette to ensure reliability and integrity of the analytical data and keeping the excellent capacity of working suitability.
By rationalizing time allocation, optimizing combination the samples in hand to keep the reasonable lead time.
By forming a good working habit to standardize experimental operations.
By checking analysis result seriously and carefully to minimize mistakes and ensure accuracy and reliability of testing figures.
Assist lab manager to coach subordinates to fulfill analysis tasks.
By providing technical support to analysts and sharing knowledge and experience within working section if necessary.
Report the abnormal status, unexpected results to supervisor with initiative and in time.
By reporting abnormal status and unexpected results during analysis processing at first time by detailed data and information to alert supervisor to investigate and solve the problem in correct way and in time.
By involving the investigation process to provide actual data and information to help avoid the same issue occurring again.
Implement the analysis method validation.
By initiating the specified analysis method validation via planning, executing and reporting process.
By organizing the resources to complete yearly method validation plan.
Implement the maintenance and calibration of the assigned instruments
By accomplishing the calibration and maintenance of the assigned instruments, to ensure they are functional well to meet the analytical needs any time.
By keeping the relevant document to trace the calibration & maintenance history and any change of the instruments.
By keeping contact with instrument company to obtain the sufficient application technical support and repair service in time.
Assist manager to support on HA lab including in-country testing and collaboration
By trouble-shooting for in-country testing
New biologics product launch preparation, e.g., reagent and consumable preparation.
Technical collaboration with HA lab, e.g., method development, method validation
Abide by lab safety regulations to prevent occurrence of accident.
By obeying the safety instruction of the storage, usage and disposal of reagent, *********, medicines, lab waste.
By following the usage instruction of facilities of water, electricity and steam etc. in lab.
By clearing the working space in time to follow company safety rule, and patrol working section at the end of working day to secure the safety of lab.
Have the ability to find and solve the problems occurred in routine work.
By finding and solving the problems in correct way and in time during the experiment process, to ensure the normal operation of routine work.
Qualification and Experience
Education/Qualifications
Bachelor of Science Degree or above
Pharmacy, Chemistry, Biochemistry and equivalent
Master at analytical science of Biological Product;
At least 4 years’ experience in analytical testing and method validation of biologics
Job Required Competencies
Project management skills
Language skills – English & **************************

其他要求

招聘人数：1人
职能类别：销售数据分析

公司介绍

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗**、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与**、医疗机构以及非**组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

更多罗氏中国信息，请登陆罗氏中国网站 ****************