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職位名稱Position Title：生產主管Production Supervisor 主要工作職責： 協助生產經理負責工廠的所有生產活動，制定和執行生產計劃和程序, 確保在預期的產量、質量及成本的基礎上有效地運用人力、物力及設備，優化生產率，達成生產目標，并確保生產活動符合公司短期和長期發展目標，符合相關健康、安全、環保和質量標準；管理并培訓員工。 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. 管理和組織生產活動 Production activities management work ü 制定、確定、修訂生產計劃,并保證生產計劃的有效執行，最大限度滿足銷售要求； Proceed, review, confirm and follow-up the manufacturing plan to satisfy the market requirement maximally； ü 根據生產計劃組織生產活動，并確保全部生產過程的運行符合GMP的要求和達到 ISO質量管理體系的標準,產品質量符合質量標準； 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、包裝等相關的生產操作及相關區域的規程； Have good knowledge about granulation, tablet compression, film-coating, package operation and relevant area regulations； ü 制定生產工藝，系統地回顧并證明其可持續穩定地生產出符合要求的產品； Develop production processes, systems and prove its review of the sustainable and stable production of products to meet the requirements； ü 制訂中間產品的質量標準； Develop quality standards of intermediate product; ü 負責生產清場開批、結批和安排各種模具的更換，最大限度地保證產量； Be responsible for the line clearance, batch start, the batch end and model change to maximize the productivity； ü 起草和回顧生產相關文件,包括批記錄,工藝規程,設備操作等的標準操作程序; Draft and review the related production documents including product batch record, standard procedure and SOPs； ü 審核和批準產品的工藝規程、操作規程等文件； Review and approve products technical rules, procedures and other documents ü 批準并監督委托生產； Approval and supervision of contract manufacturing; ü 及時向經理匯報并負責處理生產過程中的異常;負責事件和偏差的處理和改進工作 Notify the unordinary issues to the Manager in time, in charge of the disposition and improvement concerning the event and deviation; ü 參與生產運行過程的風險評估，產品回顧和生產工藝的維護工作; Involve in the risk assessment, product review and production process maintenance in the production processing; ü 協助評估并改進生產方法、設計、設備與技術； Assist evaluation and develop production method, design, equipment and technique； ü 對生產過程中的偏差進行分析，并提出糾正和預防措施； Analyze the deviation in the process of manufacturing, conduct the correct action and precaution measurement； ü 掌握設備運行狀況, 通過實時監控,控制生產過程,并對設備設施進行必要的維護監督和提出維修和改進建議，以滿足產品生產和產品質量的要求； 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驗可適應生產計劃的完成； Ensure there are adequate human resources with appropriate experience for the achievement of the manufacturing plan； ü 激勵員工的創新思維,不斷改進質量、降低成本、提高生產效率； Inspire with the people for their awareness of innovation to develop quality, decrease cost and improve the production efficiency； 2. 檢查和監督工作 check and monitor work ü 監督生產過程中各項操作的準確性和正確性，確保藥品按照批準的工藝規程生產、貯存，以保證藥品質量,符合SOP和有關規定要求； 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 確定和監控物料和產品的貯存條件； Identification and monitoring of materials and product storage conditions; ü 監督和檢查記錄的填寫，保證其正確性和真實性；確保批生產記錄和批包裝記錄經過指定人員審核并送交質量管理部門； 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 確保嚴格執行與生產操作相關的各種操作規程； Ensure the strict implementation of various production operation related procedures; ü 確保廠房和設備的維護保養，以保持其良好的運行狀態； Ensure plant and equipment maintenance to keep it in good working condition; ü 監督各機器設備的清潔，確保其衛生狀況符合GMP規范； Monitor the clean status of equipments to make sure that it meets the requirement of GMP regulations； ü 監督生產區域的潔凈，防止交叉污染，監督對生產用的設備和容器予以正確的狀態標識； Supervise the clean and prevent cross-contamination in the production area and monitor correctly label on the equipment and containers used in production； ü 監督各區域、房間衛生狀況符合GMP規范； Monitor the sanitation status of each production area and room to make sure that they meet the requirement of GMP regulations； ü 監督各崗位設備標識、產品標記、原輔料標識及包裝材料標識的準確性; Monitor the veracity of all kinds of status label such as equipment label, product label, raw materials label and package materials label; ü 監控影響產品質量的因素; Monitor the factors that affect product quality; ü 監督GMP執行狀況； Monitor the status of implementation of GMP 3. 驗證工作 Validation ü 負責生產設備,生產工藝驗證方案的起草； Responsible for preparing validation protocol of production equipments and manufacturing process； ü 按照驗證計劃實施驗證工作,確保完成各種必要的驗證工作； In charge of implementation of validation according to the protocol, ensure the completion of the necessary validations; 4. 培訓工作 Training ü 負責生產相關文件的培訓； In charge of training operators of related production documents； ü 確保生產相關人員經過必要的上崗前培訓和繼續培訓，并根據實際需要調整培訓內容; Ensure the necessary pre-service training and continuing training to the relevant persons, and training need to be adjusted according to actual content. 5. 統計工作 Statistic work ü 對生產和包裝的產量和消耗進行統計； In charge of statistic turnout and cost including manufacturing and packaging； ü 對設備的停機情況進行分析，提出改進建議。 In charge of analysis downtime of equipment and propose improvement. 6. 生產經理不在的時候，代理行使經理的職責與權力 Deputy of department manager duties and power in case of production manager absence. 7. 環境、安全、健康及質量：遵守GMP及所有EHS規定，并督導員工遵照執行； Environment, Health, Safety & Quality: to observe all GMP, EHS requirements, emphasise these standards/norms to employees and request that they adhere to them; 8. 完成生產效率和績效提高的相應項目 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，身體無過敏情況； Under 38 years old, with good image and no history of allergy； 2. 大學本科以上學歷，藥學或相關專業，具有中級專業技術職稱或執業藥師資格 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生產/工藝相關工作經驗，兩年以上從事藥品生產和質量管理的工作經驗，其中至少有一年的藥品生產管理經驗，接受過與所生產產品相關的專業知識培訓; 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規范，SOP或工藝設備； Familiar with solid preparations of GMP, SOP and process equipment; 5. CET4以上且能熟練使用英語作為工作語言； CET4 or above and good command of English as working language; 素質要求 Qualifications ? 強烈的工作責任心和敬業精神； 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調能力； Good communication skill and coordinative ability； ? 具有督導和培訓下屬的管理經驗；耐心、細致的工作態度； Having practical experiments of supervising and training subordinates; Patience needed and care for people； ? 為人誠實、正直、對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； ? 具有良好的團隊合作精神 Team Work Spirit 有意者，請發送詳細中英文簡歷 合則約見，薪資面議