崗位職責(zé):
根據(jù)生產(chǎn)指令及工藝、質(zhì)量、設(shè)備操作、安全等作業(yè)規(guī)范,執(zhí)行生產(chǎn)任務(wù),保質(zhì)保量完成車間下達(dá)的各項生產(chǎn)任務(wù)。
1. 產(chǎn)品生產(chǎn)
1) 嚴(yán)格按照生產(chǎn)產(chǎn)品的工藝規(guī)程、崗位SOP等進(jìn)行生產(chǎn)作業(yè)并及時、準(zhǔn)確地完成生產(chǎn)記錄及相關(guān)管理記錄
2) 根據(jù)車間下達(dá)的批生產(chǎn)指令單,保質(zhì)保量的按時完成每班的生產(chǎn)任務(wù)
3) 負(fù)責(zé)當(dāng)班物品及崗位文件的管理
4) 負(fù)責(zé)按照規(guī)程做好當(dāng)班清場工作及清潔消毒工作
5) 負(fù)責(zé)控制本崗位生產(chǎn)過程物料平衡
6) 及時反饋并參與解決生產(chǎn)過程中出現(xiàn)的問題
2. 質(zhì)量控制
1) 負(fù)責(zé)本崗位生產(chǎn)過程中的質(zhì)量監(jiān)控并實時記錄
2) 及時反饋異常情況
3. 原輔料管理
1) 負(fù)責(zé)根據(jù)規(guī)定量領(lǐng)用及處理原輔料及包材
2) 負(fù)責(zé)對原輔料及包材的暫時性保管
3) 負(fù)責(zé)對原輔料及包材的密封及退庫
4) 負(fù)責(zé)控制本崗位相關(guān)物料的物耗
4. 工藝設(shè)備維護(hù)
1) 根據(jù)工藝參數(shù)和設(shè)備操作規(guī)程正確操作
2) 對當(dāng)班設(shè)備、儀表、器具等日常維護(hù)、保養(yǎng),并記錄,發(fā)現(xiàn)問題及時報告
5. 安全控制
1) 嚴(yán)格執(zhí)行安全生產(chǎn)制度,生產(chǎn)中注意水電汽的使用安全
6. 人員培訓(xùn)
1) 負(fù)責(zé)本崗位新人的帶教、指導(dǎo)
Job Description:
Responsible for executing production tasks in accordance with production orders, process specifications, quality standards, equipment operation procedures, and safety regulations to ensure the completion of all assigned tasks in the workshop with both quality and quantity.
1. Product Production
1) Strictly adhere to the process procedures and SOPs for production, ensuring accurate and timely completion of production records and related management records.
2) Ensure the timely and high-quality completion of each shift sproduction tasks based on the batch production orders issued by the workshop.
3) Responsible for managing materials and documents used during shifts.
4) Perform on-shift site clearance, cleaning, and disinfection according to established procedures.
5) Control material balance during production.
6) Provide timely feedback and assist in resolving issues encountered during production.
2. Quality Control
1)Monitor the quality of production processes and record real-time data.
2) Immediately report any abnormal situations.
3. Starting Material Management
1) Responsible for the proper use and handling of starting materials and packaging materials in accordance with specified quantities.
2) Ensure the temporary storage and proper sealing of starting and packaging materials, and return unused materials to storage.
3) Control material consumption related to this position.
4. Process Equipment Maintenance
1) Operate equipment according to process parameters and equipment operation procedures.
2) Conduct routine maintenance of equipment, instruments, and tools during shift, maintain records, and promptly report any issues found.
5. Safety Control
1) Strictly follow safety production regulations, pay attention to the safe use of water, electricity, and steam during production.
6. Personnel Training
1) Responsible for training and guiding new employees in this position.
任職要求:
1. 專業(yè)及學(xué)歷
1) 大專或以上學(xué)歷
2. 專業(yè)經(jīng)驗
1) 1年以上醫(yī)藥、制藥行業(yè)企業(yè)生產(chǎn)相關(guān)工作經(jīng)驗 或
2) 1年以上醫(yī)藥、制藥行業(yè)企業(yè)生產(chǎn)相關(guān)領(lǐng)域管理工作經(jīng)驗
3. 專業(yè)知識技能
1) 了解生產(chǎn)管理、質(zhì)量管制、設(shè)備管理等基本制度、流程與規(guī)范等;熟悉生產(chǎn)工藝流程、崗位SOP操作規(guī)范、安全操作規(guī)范及GMP基礎(chǔ)知識等
2) 熟悉領(lǐng)料退庫相關(guān)規(guī)范及要求
3) 熟練掌握崗位工藝生產(chǎn)參數(shù)、設(shè)備操作及生產(chǎn)技能
4) 熟悉微生物相關(guān)知識
4. 基礎(chǔ)知識技能
1) 掌握車間批生產(chǎn)記錄、管理記錄填寫要求
5. 能力素質(zhì)
1) 具備良好的表達(dá)、溝通與團(tuán)隊協(xié)作能力
2) 具備較強的責(zé)任意識、質(zhì)量意識、安全意識與規(guī)范意識
3) 具備較強的執(zhí)行力
6. 身體素質(zhì)
1) 身體健康,無傳染病、皮膚病
1. Education & Background
1) Diploma or above.
2. Professional Experience
1) At least 1 years of relevant experience in production related field in the pharmaceutical industry; OR
2) At least 1 years of management experience in production related fields in the pharmaceutical industry
3. Professional Knowledge & Skill
1) Understand the basic regulations, processes, and standards of production management, quality control, and equipment management.
2) Familiar with production process flows, SOPs, safety protocols, and basic GMP knowledge.
3) Proficient in material handling and warehouse return protocols.
4) Skilled in production parameters, equipment operation, and production techniques for this position.
5) Knowledge of microbiology.
4. Basic Knowledge & Skill
1) Master the filling requirements for workshop batch production records and management records..
5. Competency & Quality
1) Excellent communication, collaboration, and teamwork abilities.
2) Strong sense of responsibility, quality, safety, and regulatory compliance.
3) High level of execution ability.
6. Physical Fitness
1) Good health, free from infectious diseases and skin conditions.