秋时电子科技

职位概要(Job summary): 

管理公司内部的微生物实验室和化学实验室，组织完成医疗器械的检验工作，确保检验结果的准确性和有效性。主要工作包括对产品、环境、原材料、内包材、工艺用水等进行无菌检查、微生物限度检查、细菌内毒素检查。
Manage the internal microbiology laboratory and Chemical laboratory of the company, organize the completion of medical device inspection work, and ensure the accuracy and effectiveness of inspection results. The main responsibilities include conducting aseptic testing, microbial limit testing, and bacterial endotoxin testing on products, environment, raw materials, internal packaging materials, process water, etc.

工作职责(Responsibilities):  

1.	实验室管理：负责微生物实验室和化学实验室的日常管理和运营，确保实验室各项工作符合GMP、药典和其他相关法律法规，以及公司质量体系等的相关要求。 
Laboratory Management: Responsible for the daily management and operation of Microbiology and Chemical laboratories, ensuring that all laboratory work complies with GMP, pharmacopoeia, and other relevant laws and regulations, as well as company quality management system and other related requirements.
2.	文件管理：负责起草、修订相关文件，并对现有文件提出改进及优化，确保实验室管理的规范化和标准化。 
Document management: Responsible for developing and revising relevant documents, and provide improvement and optimization for existing documents to ensure the standardization and normalization of laboratory management.
3.	方法验证：对新产品进行检验方法的摸索及方法学验证，确保检验方法的科学性和可靠性，包括无菌检查、微生物限度检查、细菌内毒素检查等方法的开发、验证和实施。
Method validation: Develop and validate the testing methods for new products, ensuring the scientific and reliable nature of the testing methods, including the development, validation, and implementation of methods such as sterility testing, microbial limit testing, and bacterial endotoxin testing.
4.	检验任务：负责微生物实验室和化学实验室的检验任务，包括对产品、原材料、内包材、环境、工艺用水等的无菌、微生物限度、内毒素、阳性实验和菌种鉴定， 以及对产品的不溶性微粒检测和EO/ECH残留检测、对工艺用水的化学检验等。
Inspection tasks: Responsible for the inspection tasks of microbiology laboratory and chemical laboratory, including sterility, microbial limits, endotoxins, positive experiments and strain identification of products, raw materials, internal packaging materials, environment, process water, etc., as well as insoluble particle detection and EO/ECH residue detection of products, chemical inspection of process water, etc.
5.	环境监测：负责洁净区的环境监测计划的制定及日常监测，统计和分析数据。
Environmental Monitoring: Responsible for environmental monitoring plans for clean areas, conducting daily monitoring, and collecting and analyzing data.
6.	团队管理：负责对检验人员进行岗位培训和技术指导、监督、管理 。 
Team management: Responsible for providing job training, technical guidance, supervision, and management to inspection personnel.
7.	设备管理：参与微生物实验和化学实验相关的仪器设备及计算机化系统的验证及管理工作。 
Equipment management: Participate in the validation and management of instruments, equipment, and computerized systems related to microbiological and chemical experiments.
8.	物料管理：负责实验室的各类物料管理，包括样品、菌种、生物指示剂、培养基、试剂耗材等。
Material Management: Responsible for managing various materials in the laboratory, including samples, strains, biological indicators, culture media, reagents, consumables, etc.
9.	数据分析和异常处理：对关键检测数据进行定期的趋势分析，对相关检验过程中出现的偏差、OOS/OOT等实验室异常的调查处理。
Data analysis and anomaly handling: Conduct regular trend analysis on key detection data, investigate and handle laboratory anomalies such as deviations and OOS/OOT that occur during the relevant inspection process.

任职资格(Qualification) :
1. 教育背景：全日制本科及以上学历，生物工程、微生物、医药、应用化学等相关专业。 
Education background: Full time bachelor's degree or above, major in biotechnology, microbiology, medicine, applied chemistry, or related fields.
2. 工作经验：5年及以上相关医疗器械行业微生物实验室工作经验，熟悉中美欧GMP和CHP/USP/EP药典对无菌和微生物控制的相关技术和方法要求，包括微生物限度检查、无菌检查、细菌内毒素检查等，能够独立编写微生物相关SOP、方案报告; 熟悉各类检验仪器的使用和维护； 有医疗器械无菌检验员证书。
Work experience: more than 5 years relevant experience in microbiology laboratories in the medical device industry, familiar with the technical and methodological requirements for sterility and microbiological control in the GMP and CHP/USP/EP pharmacopoeias of China, the United States, and Europe, including microbiological limit testing, sterility testing, bacterial endotoxin testing, etc., Able to independently write microbiology related SOPs, protocol and reports; Familiar with the use and maintenance of various inspection instruments; Has a certificate as a sterile inspector for medical devices.
3. 技能要求：有团队管理经验，具备良好的组织管理、计划、协调和沟通能力，问题分析和解决能力，能够有效地管理团队和实验室的日常运营；需要具备风险规避和防范意识，确保实验室工作的安全和质量 。
Skills required: Have team management experience, good organizational management, planning, coordination, and communication skills, problem analysis and resolution abilities, and be able to effectively manage the daily operations of teams and laboratories; Risk avoidance and prevention awareness are required to ensure the safety and quality of laboratory work.
4. 英语技能：CET-4以上，具备英文听说读写能力，能阅读国外药典和标准。
English skills: CET-4 or above, with English listening, speaking, reading, and writing abilities, able to read foreign pharmacopoeias and standards.