崗位職責: 根據生產指令及工藝、質量、設備操作、安全等作業規范，執行生產任務，保質保量完成車間下達的各項生產任務。 1. 產品生產 1) 嚴格按照生產產品的工藝規程、崗位SOP等進行生產作業并及時、準確地完成生產記錄及相關管理記錄 2) 根據車間下達的批生產指令單，保質保量的按時完成每班的生產任務 3) 負責當班物品及崗位文件的管理 4) 負責按照規程做好當班清場工作及清潔消毒工作 5) 負責控制本崗位生產過程物料平衡 6) 及時反饋并參與解決生產過程中出現的問題 2. 質量控制 1) 負責本崗位生產過程中的質量監控并實時記錄 2) 及時反饋異常情況 3. 原輔料管理 1) 負責根據規定量領用及處理原輔料及包材 2) 負責對原輔料及包材的暫時性保管 3) 負責對原輔料及包材的密封及退庫 4) 負責控制本崗位相關物料的物耗 4. 工藝設備維護 1) 根據工藝參數和設備操作規程正確操作 2) 對當班設備、儀表、器具等日常維護、保養，并記錄，發現問題及時報告 5. 安全控制 1) 嚴格執行安全生產制度，生產中注意水電汽的使用安全 6. 人員培訓 1) 負責本崗位新人的帶教、指導 Job Description: Responsible fexecuting production tasks in accordance with productionders, process specifications, quality standards, equipment operation procedures, safety regulations to ensure the completion of all assigned tasks in the workshop with both quality quantity. 1. Product Production 1) Strictly adhere to the process procedures SOPs fproduction, ensuring accurate timely completion of production records related management records. 2) Ensure the timely high-quality completion of each shift sproduction tasks based on the batch productionders issued by the workshop. 3) Responsible fmanaging materials documents used during shifts. 4) Perform on-shift site clearance, cleaning, disinfection according to established procedures. 5) Control material balance during production. 6) Provide timely feedback assist in resolving issues encountered during production. 2. Quality Control 1）Monitthe quality of production processes record real-time data. 2) Immediately report any abnormal situations. 3. Starting Material Management 1) Responsible fthe proper use handling of starting materials packaging materials in accordance with specified quantities. 2) Ensure the temporary storage proper sealing of starting packaging materials, return unused materials to storage. 3) Control material consumption related to this position. 4. Process Equipment Maintenance 1) Operate equipment according to process parameters equipment operation procedures. 2) Conduct routine maintenance of equipment, instruments, tools during shift, maintain records, promptly report any issues found. 5. Safety Control 1) Strictly follow safety production regulations, pay attention to the safe use of water, electricity, steam during production. 6. Personnel Training 1) Responsible ftraining guiding new employees in this position. 任職要求: 1. 專業及學歷 1) 大專或以上學歷 2. 專業經驗 1) 1年以上醫藥、制藥行業企業生產相關工作經驗 或 2) 1年以上醫藥、制藥行業企業生產相關領域管理工作經驗 3. 專業知識技能 1) 了解生產管理、質量管制、設備管理等基本制度、流程與規范等；熟悉生產工藝流程、崗位SOP操作規范、安全操作規范及GMP基礎知識等 2) 熟悉領料退庫相關規范及要求 3) 熟練掌握崗位工藝生產參數、設備操作及生產技能 4) 熟悉微生物相關知識 4. 基礎知識技能 1) 掌握車間批生產記錄、管理記錄填寫要求 5. 能力素質 1) 具備良好的表達、溝通與團隊協作能力 2) 具備較強的責任意識、質量意識、安全意識與規范意識 3) 具備較強的執行力 6. 身體素質 1) 身體健康，無傳染病、皮膚病 1. Education & Background 1) Diploma above. 2. Professional Experience 1) At least 1 years of relevant experience in production related field in the pharmaceutical industry; 2) At least 1 years of management experience in production related fields in the pharmaceutical industry 3. Professional Knowledge & Skill 1) Understthe basic regulations, processes, standards of production management, quality control, equipment management. 2) Familiar with production process flows, SOPs, safety protocols, basic GMP knowledge. 3) Proficient in material handling warehouse return protocols. 4) Skilled in production parameters, equipment operation, production techniques fthis position. 5) Knowledge of microbiology. 4. Basic Knowledge & Skill 1) Master the filling requirements fworkshop batch production records management records.. 5. Competency & Quality 1) Excellent communication, collaboration, teamwork abilities. 2) Strong sense of responsibility, quality, safety, regulatory compliance. 3) High level of execution ability. 6. Physical Fitness 1) Good health, free from infectious diseases skin conditions.
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