崗位職責:
一、設(shè)備管理 Equipment acceptance management
1. 負責對設(shè)備進行全生命周期管理,設(shè)備的進場驗收、安裝和調(diào)試,設(shè)備標簽和標識牌發(fā)放、設(shè)備技術(shù)檔案的歸檔等
Be responsible for the whole life cycle management of equipment, the mobilization acceptance, installation and commissioning of equipment, the issuance of equipment labels and identification plates, and the filing of equipment technical archives, etc.
2. 負責設(shè)備的FAT、SAT和IOQ的驗收工作
Responsible for the acceptance of FAT, SAT and IOQ of the equipment
3. 負責公司工藝設(shè)備的維護保養(yǎng)工作,確保生產(chǎn)的正常運行;
Responsible for the maintenance of the company's process equipment to ensure the normal operation of production.
4. 負責工藝設(shè)備故障及時組織處理,確保設(shè)備始終處于良好的運行狀態(tài);
Responsible for the timely organization and treatment of process equipment failures to ensure that the equipment is always in good operating condition.
5. 負責工藝設(shè)備偏差、變更、CAPA的發(fā)起、審核、跟進
Responsible for the initiation, review and follow-up of process equipment deviation, change and CAPA
二、文件管理Document Management
1. 負責本部門工藝設(shè)備管理文件、維保作業(yè)指導書的起草,并按照SOP要求嚴格執(zhí)行
Responsible for the drafting of the department's process equipment management documents and maintenance work instructions, and strictly implement them according to SOP requirements
2. 負責SAP PM模塊SOP和作業(yè)指導書的起草,并按照SOP要求嚴格執(zhí)行
Responsible for the drafting of SOP and work instructions for SAP PM modules, and strictly implement them according to SOP requirements
三、培訓管理Training Management
1. 按時完成TMS系統(tǒng)下達的各項培訓
Complete all training issued by TMS system on time
2. 按時完成本部門起草/升版的培訓
Complete the training of the department's draft/upgrade version on time
四、 組織管理Organizational Management
1. 工作計劃:按照分配的工作任務(wù)制定工作計劃,并實施
Work plan: Develop a work plan in accordance with the assigned work tasks and implement it
2. 部門會議:參加部門會議,積極反饋相關(guān)的工作內(nèi)容
Departmental meetings: Attend departmental meetings and provide active feedback on relevant work content
3. 績效考核:根據(jù)公司管理要求制訂績效計劃
Performance appraisal: Develop performance plans according to company management requirements
任職要求:
本科以上要求
Bachelor degree or above required
有藥品生產(chǎn)企業(yè)五年以上工作經(jīng)驗,熟悉大部分藥廠設(shè)備
More than 5 years working experience in pharmaceutical manufacturing company, familiar with most pharmaceutical equipment
熟練掌握GMP指南要求以及各國家法規(guī)對工藝設(shè)備的要求
Good command of GMP guidelines and national regulations on process equipment requirements
熟練掌握設(shè)備維修維護技術(shù);具有良好的團隊協(xié)作能力以及溝通協(xié)調(diào)能力
Proficient in equipment maintenance technology; Good teamwork and communication skills
具有良好的英文讀寫能力優(yōu)先;
Good English reading and writing skills are preferred;