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職位名稱(chēng)Position Title：生產(chǎn)主管Production Supervisor 主要工作職責(zé)： 協(xié)助生產(chǎn)經(jīng)理負(fù)責(zé)工廠的所有生產(chǎn)活動(dòng)，制定和執(zhí)行生產(chǎn)計(jì)劃和程序, 確保在預(yù)期的產(chǎn)量、質(zhì)量及成本的基礎(chǔ)上有效地運(yùn)用人力、物力及設(shè)備，優(yōu)化生產(chǎn)率，達(dá)成生產(chǎn)目標(biāo)，并確保生產(chǎn)活動(dòng)符合公司短期和長(zhǎng)期發(fā)展目標(biāo)，符合相關(guān)健康、安全、環(huán)保和質(zhì)量標(biāo)準(zhǔn)；管理并培訓(xùn)員工。 Main responsibilities：Assist production manager to be responsible for all the production activities, develop and implement manufacturing plan and procedures, allocate labor, material resource and equipment to ensure achievements of production objectives and keep optimizing productivity; ensure all production activities to meet short and long-term business objectives of the plant, and are conducted in accordance with GMP/CSR/EHS standards；manage and train subordinates. ? 具體如下：Details are as following： 1. 管理和組織生產(chǎn)活動(dòng) Production activities management work ü 制定、確定、修訂生產(chǎn)計(jì)劃,并保證生產(chǎn)計(jì)劃的有效執(zhí)行，最大限度滿足銷(xiāo)售要求； Proceed, review, confirm and follow-up the manufacturing plan to satisfy the market requirement maximally； ü 根據(jù)生產(chǎn)計(jì)劃組織生產(chǎn)活動(dòng)，并確保全部生產(chǎn)過(guò)程的運(yùn)行符合GMP的要求和達(dá)到 ISO質(zhì)量管理體系的標(biāo)準(zhǔn),產(chǎn)品質(zhì)量符合質(zhì)量標(biāo)準(zhǔn)； Organize manufacturing activities according to the production plan, monitor the total process and ensure that they are in accordance with the requirement of GMP and ISO Quality Assurance System； ü 熟悉造粒、壓片、包衣、包裝等相關(guān)的生產(chǎn)操作及相關(guān)區(qū)域的規(guī)程； Have good knowledge about granulation, tablet compression, film-coating, package operation and relevant area regulations； ü 制定生產(chǎn)工藝，系統(tǒng)地回顧并證明其可持續(xù)穩(wěn)定地生產(chǎn)出符合要求的產(chǎn)品； Develop production processes, systems and prove its review of the sustainable and stable production of products to meet the requirements； ü 制訂中間產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)； Develop quality standards of intermediate product; ü 負(fù)責(zé)生產(chǎn)清場(chǎng)開(kāi)批、結(jié)批和安排各種模具的更換，最大限度地保證產(chǎn)量； Be responsible for the line clearance, batch start, the batch end and model change to maximize the productivity； ü 起草和回顧生產(chǎn)相關(guān)文件,包括批記錄,工藝規(guī)程,設(shè)備操作等的標(biāo)準(zhǔn)操作程序; Draft and review the related production documents including product batch record, standard procedure and SOPs； ü 審核和批準(zhǔn)產(chǎn)品的工藝規(guī)程、操作規(guī)程等文件； Review and approve products technical rules, procedures and other documents ü 批準(zhǔn)并監(jiān)督委托生產(chǎn)； Approval and supervision of contract manufacturing; ü 及時(shí)向經(jīng)理匯報(bào)并負(fù)責(zé)處理生產(chǎn)過(guò)程中的異常;負(fù)責(zé)事件和偏差的處理和改進(jìn)工作 Notify the unordinary issues to the Manager in time, in charge of the disposition and improvement concerning the event and deviation; ü 參與生產(chǎn)運(yùn)行過(guò)程的風(fēng)險(xiǎn)評(píng)估，產(chǎn)品回顧和生產(chǎn)工藝的維護(hù)工作; Involve in the risk assessment, product review and production process maintenance in the production processing; ü 協(xié)助評(píng)估并改進(jìn)生產(chǎn)方法、設(shè)計(jì)、設(shè)備與技術(shù)； Assist evaluation and develop production method, design, equipment and technique； ü 對(duì)生產(chǎn)過(guò)程中的偏差進(jìn)行分析，并提出糾正和預(yù)防措施； Analyze the deviation in the process of manufacturing, conduct the correct action and precaution measurement； ü 掌握設(shè)備運(yùn)行狀況, 通過(guò)實(shí)時(shí)監(jiān)控,控制生產(chǎn)過(guò)程,并對(duì)設(shè)備設(shè)施進(jìn)行必要的維護(hù)監(jiān)督和提出維修和改進(jìn)建議，以滿足產(chǎn)品生產(chǎn)和產(chǎn)品質(zhì)量的要求； Keep the equipments in running status, monitor the whole manufacturing process automatically, and implement maintains and repair work in advance if necessary to meet the requirements of product manufacture and quality； ü 確保員工資源及其經(jīng)驗(yàn)可適應(yīng)生產(chǎn)計(jì)劃的完成； Ensure there are adequate human resources with appropriate experience for the achievement of the manufacturing plan； ü 激勵(lì)員工的創(chuàng)新思維,不斷改進(jìn)質(zhì)量、降低成本、提高生產(chǎn)效率； Inspire with the people for their awareness of innovation to develop quality, decrease cost and improve the production efficiency； 2. 檢查和監(jiān)督工作 check and monitor work ü 監(jiān)督生產(chǎn)過(guò)程中各項(xiàng)操作的準(zhǔn)確性和正確性，確保藥品按照批準(zhǔn)的工藝規(guī)程生產(chǎn)、貯存，以保證藥品質(zhì)量,符合SOP和有關(guān)規(guī)定要求； Monitor the precious and accuracy of every operation in the whole manufacturing processes to be sure that it meet the requirements of approved technical rules, the drug production and storage, to ensure drug quality and in accordance with SOPs and relevant regulations； ü 確定和監(jiān)控物料和產(chǎn)品的貯存條件； Identification and monitoring of materials and product storage conditions; ü 監(jiān)督和檢查記錄的填寫(xiě)，保證其正確性和真實(shí)性；確保批生產(chǎn)記錄和批包裝記錄經(jīng)過(guò)指定人員審核并送交質(zhì)量管理部門(mén)； Monitor and check the records to be sure that records are correctly and truly；ensure that the batch records and batch packaging record had been reviewed by the specified person and hand them over to quality department; ü 確保嚴(yán)格執(zhí)行與生產(chǎn)操作相關(guān)的各種操作規(guī)程； Ensure the strict implementation of various production operation related procedures; ü 確保廠房和設(shè)備的維護(hù)保養(yǎng)，以保持其良好的運(yùn)行狀態(tài)； Ensure plant and equipment maintenance to keep it in good working condition; ü 監(jiān)督各機(jī)器設(shè)備的清潔，確保其衛(wèi)生狀況符合GMP規(guī)范； Monitor the clean status of equipments to make sure that it meets the requirement of GMP regulations； ü 監(jiān)督生產(chǎn)區(qū)域的潔凈，防止交叉污染，監(jiān)督對(duì)生產(chǎn)用的設(shè)備和容器予以正確的狀態(tài)標(biāo)識(shí)； Supervise the clean and prevent cross-contamination in the production area and monitor correctly label on the equipment and containers used in production； ü 監(jiān)督各區(qū)域、房間衛(wèi)生狀況符合GMP規(guī)范； Monitor the sanitation status of each production area and room to make sure that they meet the requirement of GMP regulations； ü 監(jiān)督各崗位設(shè)備標(biāo)識(shí)、產(chǎn)品標(biāo)記、原輔料標(biāo)識(shí)及包裝材料標(biāo)識(shí)的準(zhǔn)確性; Monitor the veracity of all kinds of status label such as equipment label, product label, raw materials label and package materials label; ü 監(jiān)控影響產(chǎn)品質(zhì)量的因素; Monitor the factors that affect product quality; ü 監(jiān)督GMP執(zhí)行狀況； Monitor the status of implementation of GMP 3. 驗(yàn)證工作 Validation ü 負(fù)責(zé)生產(chǎn)設(shè)備,生產(chǎn)工藝驗(yàn)證方案的起草； Responsible for preparing validation protocol of production equipments and manufacturing process； ü 按照驗(yàn)證計(jì)劃實(shí)施驗(yàn)證工作,確保完成各種必要的驗(yàn)證工作； In charge of implementation of validation according to the protocol, ensure the completion of the necessary validations; 4. 培訓(xùn)工作 Training ü 負(fù)責(zé)生產(chǎn)相關(guān)文件的培訓(xùn)； In charge of training operators of related production documents； ü 確保生產(chǎn)相關(guān)人員經(jīng)過(guò)必要的上崗前培訓(xùn)和繼續(xù)培訓(xùn)，并根據(jù)實(shí)際需要調(diào)整培訓(xùn)內(nèi)容; Ensure the necessary pre-service training and continuing training to the relevant persons, and training need to be adjusted according to actual content. 5. 統(tǒng)計(jì)工作 Statistic work ü 對(duì)生產(chǎn)和包裝的產(chǎn)量和消耗進(jìn)行統(tǒng)計(jì)； In charge of statistic turnout and cost including manufacturing and packaging； ü 對(duì)設(shè)備的停機(jī)情況進(jìn)行分析，提出改進(jìn)建議。 In charge of analysis downtime of equipment and propose improvement. 6. 生產(chǎn)經(jīng)理不在的時(shí)候，代理行使經(jīng)理的職責(zé)與權(quán)力 Deputy of department manager duties and power in case of production manager absence. 7. 環(huán)境、安全、健康及質(zhì)量：遵守GMP及所有EHS規(guī)定，并督導(dǎo)員工遵照?qǐng)?zhí)行； Environment, Health, Safety & Quality: to observe all GMP, EHS requirements, emphasise these standards/norms to employees and request that they adhere to them; 8. 完成生產(chǎn)效率和績(jī)效提高的相應(yīng)項(xiàng)目 Complete assigned projects/tasks based on site & dept. performance leader’s arrangement. ? 基本要求 Basic Requirements 1. 38歲以下，形象端正，身體無(wú)過(guò)敏情況； Under 38 years old, with good image and no history of allergy； 2. 大學(xué)本科以上學(xué)歷，藥學(xué)或相關(guān)專(zhuān)業(yè)，具有中級(jí)專(zhuān)業(yè)技術(shù)職稱(chēng)或執(zhí)業(yè)藥師資格 Should at least have the bachelor’s degree or above, major in pharmacy or related (Intermediate professional titles or Licensed Pharmacist), 3. 五年以上外資制藥企業(yè)生產(chǎn)/工藝相關(guān)工作經(jīng)驗(yàn)，兩年以上從事藥品生產(chǎn)和質(zhì)量管理的工作經(jīng)驗(yàn)，其中至少有一年的藥品生產(chǎn)管理經(jīng)驗(yàn)，接受過(guò)與所生產(chǎn)產(chǎn)品相關(guān)的專(zhuān)業(yè)知識(shí)培訓(xùn); More than 5 years working experience in pharmaceutical production/process in FIE pharma. At least two years’ experience in the pharmaceutical manufacturing and quality management, including at least one year experience in pharmaceutical production management, received with the production of product-related knowledge and skill training; 4. 熟悉固體制劑GMP規(guī)范，SOP或工藝設(shè)備； Familiar with solid preparations of GMP, SOP and process equipment; 5. CET4以上且能熟練使用英語(yǔ)作為工作語(yǔ)言； CET4 or above and good command of English as working language; 素質(zhì)要求 Qualifications ? 強(qiáng)烈的工作責(zé)任心和敬業(yè)精神； Commitment to success and accountability； ? 良好的組織和管理能力； Good organization and management ability； ? 良好的溝通技巧和協(xié)調(diào)能力； Good communication skill and coordinative ability； ? 具有督導(dǎo)和培訓(xùn)下屬的管理經(jīng)驗(yàn)；耐心、細(xì)致的工作態(tài)度； Having practical experiments of supervising and training subordinates; Patience needed and care for people； ? 為人誠(chéng)實(shí)、正直、對(duì)事物具有正確的判斷力和解決能力； Honest and integrity, good at problem solving； ? 能在壓力下保持高效率的工作； Ability of keeping high efficiency on work under high pressure； ? 具有良好的團(tuán)隊(duì)合作精神 Team Work Spirit 有意者，請(qǐng)發(fā)送詳細(xì)中英文簡(jiǎn)歷 合則約見(jiàn)，薪資面議