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1 工作職責(zé) / Job Responsibilities 1.1 負(fù)責(zé)制藥生產(chǎn)設(shè)備的全生命周期管理，包括選型、安裝、調(diào)試、維護(hù)及退役。 Manage the entire lifecycle of pharmaceutical production equipment, including selection, installation, commissioning, maintenance, and decommissioning. 1.2 主導(dǎo)或協(xié)助完成設(shè)備驗(yàn)證（IQ/OQ/PQ）及再驗(yàn)證工作，確保符合GMP、FDA、EMA等法規(guī)要求。 Lead or support equipment validation (IQ/OQ/PQ) and revalidation activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements. 1.3 制定和更新設(shè)備管理及驗(yàn)證相關(guān)SOP，并監(jiān)督執(zhí)行。 Develop and update SOPs related to equipment management and validation, and ensure implementation. 1.4 協(xié)調(diào)跨部門（生產(chǎn)、工程、QC、QA）完成設(shè)備相關(guān)變更、偏差及CAPA處理。 Coordinate cross-functional teams (Production, Engineering, QC, QA) to address equipment-related changes, deviations, and CAPAs. 1.5 負(fù)責(zé)設(shè)備檔案管理，確保文檔完整、可追溯。 Maintain equipment documentation to ensure traceability and compliance. 1.6 參與內(nèi)外部審計(jì)，提供設(shè)備管理及驗(yàn)證領(lǐng)域的支持。 Support internal and external audits in the areas of equipment management and validation. 2 任職要求 / Qualifications 2.1 教育背景：本科及以上學(xué)歷，藥學(xué)、機(jī)械工程、自動(dòng)化或相關(guān)專業(yè)。 Education: Bachelor’s degree or above in Pharmacy, Mechanical Engineering, Automation, or related fields. 2.2 經(jīng)驗(yàn)要求：3年以上制藥行業(yè)設(shè)備管理或驗(yàn)證工作經(jīng)驗(yàn)，熟悉GMP法規(guī)。 Experience:3+ years in equipment management or validation within the pharmaceutical industry, with knowledge of GMP regulations. 2.3 技能要求： 熟悉制藥設(shè)備（如制劑設(shè)備、滅菌柜、 HVAC等）的驗(yàn)證流程。 能獨(dú)立撰寫驗(yàn)證方案、報(bào)告及技術(shù)文件（中英文）。 熟練使用辦公軟件及數(shù)據(jù)分析工具。 Skills: Hands-on experience in pharmaceutical equipment validation (e.g., formulation equipment, autoclaves, HVAC). Ability to draft validation protocols, reports, and technical documents in both Chinese and English. Proficiency in MS Office and data analysis tools. 2.4 其他： 良好的溝通能力及團(tuán)隊(duì)協(xié)作精神。 英語(yǔ)讀寫流利（需處理英文文檔）。 2.5 Others: Strong communication and teamwork skills. Fluent in written English (for handling regulatory documents). 2.6 優(yōu)先條件 / Preferred Qualifications 有FDA/EMA認(rèn)證項(xiàng)目經(jīng)驗(yàn)者優(yōu)先。 熟悉計(jì)算機(jī)化系統(tǒng)驗(yàn)證（CSV）或21 CFR Part 11要求者優(yōu)先。 Experience in FDA/EMA-certified projects is a plus. Knowledge of CSV or 21 CFR Part 11 requirements is preferred.