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職位概要(Job summary):
管理公司內(nèi)部的微生物實(shí)驗(yàn)室和化學(xué)實(shí)驗(yàn)室，組織完成醫(yī)療器械的檢驗(yàn)工作，確保檢驗(yàn)結(jié)果的準(zhǔn)確性和有效性。主要工作包括對(duì)產(chǎn)品、環(huán)境、原材料、內(nèi)包材、工藝用水等進(jìn)行無(wú)菌檢查、微生物限度檢查、細(xì)菌內(nèi)毒素檢查。
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.
工作職責(zé)(Responsibilities):
1. 實(shí)驗(yàn)室管理：負(fù)責(zé)微生物實(shí)驗(yàn)室和化學(xué)實(shí)驗(yàn)室的日常管理和運(yùn)營(yíng)，確保實(shí)驗(yàn)室各項(xiàng)工作符合GMP、藥典和其他相關(guān)法律法規(guī)，以及公司質(zhì)量體系等的相關(guān)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：負(fù)責(zé)起草、修訂相關(guān)文件，并對(duì)現(xiàn)有文件提出改進(jìn)及優(yōu)化，確保實(shí)驗(yàn)室管理的規(guī)范化和標(biāo)準(zhǔn)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. 方法驗(yàn)證：對(duì)新產(chǎn)品進(jìn)行檢驗(yàn)方法的摸索及方法學(xué)驗(yàn)證，確保檢驗(yàn)方法的科學(xué)性和可靠性，包括無(wú)菌檢查、微生物限度檢查、細(xì)菌內(nèi)毒素檢查等方法的開(kāi)發(fā)、驗(yàn)證和實(shí)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. 檢驗(yàn)任務(wù)：負(fù)責(zé)微生物實(shí)驗(yàn)室和化學(xué)實(shí)驗(yàn)室的檢驗(yàn)任務(wù)，包括對(duì)產(chǎn)品、原材料、內(nèi)包材、環(huán)境、工藝用水等的無(wú)菌、微生物限度、內(nèi)毒素、陽(yáng)性實(shí)驗(yàn)和菌種鑒定， 以及對(duì)產(chǎn)品的不溶性微粒檢測(cè)和EO/ECH殘留檢測(cè)、對(duì)工藝用水的化學(xué)檢驗(yàn)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. 環(huán)境監(jiān)測(cè)：負(fù)責(zé)潔凈區(qū)的環(huán)境監(jiān)測(cè)計(jì)劃的制定及日常監(jiān)測(cè)，統(tǒng)計(jì)和分析數(shù)據(jù)。
Environmental Monitoring: Responsible for environmental monitoring plans for clean areas, conducting daily monitoring, and collecting and analyzing data.
6. 團(tuán)隊(duì)管理：負(fù)責(zé)對(duì)檢驗(yàn)人員進(jìn)行崗位培訓(xùn)和技術(shù)指導(dǎo)、監(jiān)督、管理 。
Team management: Responsible for providing job training, technical guidance, supervision, and management to inspection personnel.
7. 設(shè)備管理：參與微生物實(shí)驗(yàn)和化學(xué)實(shí)驗(yàn)相關(guān)的儀器設(shè)備及計(jì)算機(jī)化系統(tǒng)的驗(yàn)證及管理工作。
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：負(fù)責(zé)實(shí)驗(yàn)室的各類(lèi)物料管理，包括樣品、菌種、生物指示劑、培養(yǎng)基、試劑耗材等。
Material Management: Responsible for managing various materials in the laboratory, including samples, strains, biological indicators, culture media, reagents, consumables, etc.
9. 數(shù)據(jù)分析和異常處理：對(duì)關(guān)鍵檢測(cè)數(shù)據(jù)進(jìn)行定期的趨勢(shì)分析，對(duì)相關(guān)檢驗(yàn)過(guò)程中出現(xiàn)的偏差、OOS/OOT等實(shí)驗(yàn)室異常的調(diào)查處理。
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.
任職資格(Qualification) :
教育背景：本科及以上學(xué)歷，生物工程、微生物、醫(yī)藥、應(yīng)用化學(xué)等相關(guān)專(zhuān)業(yè)。
Education background: Full time bachelor's degree or above, major in biotechnology, microbiology, medicine, applied chemistry, or related fields.
工作經(jīng)驗(yàn)：5年及以上相關(guān)醫(yī)療器械行業(yè)微生物實(shí)驗(yàn)室工作經(jīng)驗(yàn)，熟悉中美歐GMP和CHP/USP/EP藥典對(duì)無(wú)菌和微生物控制的相關(guān)技術(shù)和方法要求，包括微生物限度檢查、無(wú)菌檢查、細(xì)菌內(nèi)毒素檢查等，能夠獨(dú)立編寫(xiě)微生物相關(guān)SOP、方案報(bào)告; 熟悉各類(lèi)檢驗(yàn)儀器的使用和維護(hù)； 有醫(yī)療器械無(wú)菌檢驗(yàn)員證書(shū)。
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.
技能要求：有團(tuán)隊(duì)管理經(jīng)驗(yàn)，具備良好的組織管理、計(jì)劃、協(xié)調(diào)和溝通能力，問(wèn)題分析和解決能力，能夠有效地管理團(tuán)隊(duì)和實(shí)驗(yàn)室的日常運(yùn)營(yíng)；需要具備風(fēng)險(xiǎn)規(guī)避和防范意識(shí)，確保實(shí)驗(yàn)室工作的安全和質(zhì)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.
英語(yǔ)技能：CET-4以上，具備英文聽(tīng)說(shuō)讀寫(xiě)能力，能閱讀國(guó)外藥典和標(biāo)準(zhǔn)。
English skills: CET-4 or above, with English listening, speaking, reading, and writing abilities, able to read foreign pharmacopoeias and standards.