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Job Responsibilities 崗位職責(zé)
1. Participate in continuous improvement of the engineering and validation related management documents and process, such as validation master plan, system validation plan, validation related SMP, maintenance plan, calibration plan, pest control plan and engineering related SMP.
參與工程及驗證相關(guān)管理文件和流程的改進(jìn)，如驗證主計劃，系統(tǒng)驗證計劃，驗證相關(guān)SMP，維護(hù)計劃，校準(zhǔn)計劃，蟲害管理計劃及工程相關(guān)SMP。
2. Supervise the execution of qualification and validation for the facilities, utilities, system, computerized system and APS. Ensure the qualification and validation meet GMP requirements.
監(jiān)督完成廠房設(shè)施，公用設(shè)施，系統(tǒng)，計算機(jī)化系統(tǒng)和無菌工藝模擬等的確認(rèn)和驗證的執(zhí)行，確保確認(rèn)和驗證符合GMP要求；
3. Supervise new equipment qualification activity, including URS, risk assessment, D/I/O/PQ and ensure the qualification meet GMP requirements.
監(jiān)督新系統(tǒng)的確認(rèn)工作，包括URS，風(fēng)險評估，D/I/O/PQ，確保確認(rèn)符合GMP要求；
4. Participate to handle the quality events (deviation/CAP/change control/OOS) about engineering and validation for the facilities, utilities, system, computerized system and APS.
參與處理工程及廠房設(shè)施，公用設(shè)施，系統(tǒng)，計算機(jī)化系統(tǒng)和無菌工藝模擬等的質(zhì)量事件（偏差/CAPA/變更/OOS）；
5. Complete facility and utility inspections regularly
定期完成公用設(shè)施巡檢；
6. Participate in the internal and external audit.
參與內(nèi)外審計；
7. Participate in Computerized System Validation work in collaboration with Subject Matter Experts.
與主題專家合作，參與計算機(jī)化系統(tǒng)驗證工作；
8. Participate in the engineering and qualification work in new project.
參與新項目的工程及確認(rèn)工作。
Qualification 任職資格
1. Bachelor degree and above or equivalent.
本科及以上或同等學(xué)歷。
2. A minimum of 2 years of experience in validation within pharmaceutical or medical device industries or at least 3 years of pharmaceutical industry experience without formal qualifications experience.
具備至少三年制藥或醫(yī)療器械行業(yè)的驗證經(jīng)驗，或無驗證經(jīng)驗但有至少五年制藥行業(yè)經(jīng)驗。
3. Understand validation and qualification process defined in cGMP, regulation and other guideline such as ISPE commissioning and qualification.
理解cGMP，法規(guī)和其他指南中定義的驗證和確認(rèn)流程，如ISPE調(diào)試和確認(rèn)；
4. Understand the operation principle of critical systems (e.g. sterilizers, isolators, PW, WFI, Pure Steam, Compressed Gasses, HVAC, filling line).
理解關(guān)鍵系統(tǒng)的運(yùn)行原理（滅菌器，隔離器，純化水系統(tǒng)，注射用水系統(tǒng)，純蒸汽系統(tǒng)，壓縮空氣系統(tǒng)，HVAC，灌裝線）；
5. Basic knowledge of Good Engineering Practices encompassing system design, factory testing, and commissioning.
具有基本的工程實(shí)踐知識，包括系統(tǒng)設(shè)計、工廠測試和調(diào)試；
6. Proficient in common Microsoft office and other working software.
精通微軟office和其他工作軟件
7. Basic English reading and writing skills.
基本的英語讀寫能力。