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負(fù)責(zé)從設(shè)計(jì)到運(yùn)營(yíng)、放行、持續(xù)改進(jìn)和退役的設(shè)施GMP設(shè)備和設(shè)施驗(yàn)證生命周期的各個(gè)方面。
Responsible for all aspects of the Facility GMP equipment and facility validation lifecycle from design through operation, release, continuous improvement and retirement.
?負(fù)責(zé)廠房GMP設(shè)備/公用設(shè)施(例如純化水系統(tǒng)，壓縮空氣系統(tǒng)，環(huán)境監(jiān)視系統(tǒng))和受控工作環(huán)境(例如，潔凈室，倉(cāng)庫(kù))的調(diào)試與驗(yàn)證工作
Responsible for commissioning and qualification of Facility GMP equipment/utilities (e.g. Purified Water System, Compressed Air System, Environment Monitoring System) and Control Work Environment (e.g. Clean Room, Warehouse)
?負(fù)責(zé)準(zhǔn)備驗(yàn)證文件，包括但不限于驗(yàn)證草案、風(fēng)險(xiǎn)評(píng)估、定期審查。
Responsible for preparation of validation documentation such as but not limited to qualification protocols, risk assessments, periodic reviews.
?起草，審閱和批準(zhǔn)設(shè)備驗(yàn)證所需的技術(shù)文件
Author, review and approve technical documents needed for qualification of equipment
?負(fù)責(zé)日常運(yùn)營(yíng)的廠房蟲害防治規(guī)程，管理蟲害供應(yīng)商，確保cGMP法規(guī)符合性。
Responsible for routine Pest Control procedure, vendor management and ensure cGMP regulatory compliance.
?負(fù)責(zé)日常運(yùn)營(yíng)的廠房設(shè)施儀表的校驗(yàn)規(guī)程，管理校驗(yàn)供應(yīng)商，確保cGMP法規(guī)符合性。
Responsible for routine Facility Instrument Calibration procedure, vendor management and ensure cGMP regulatory compliance.
?確保新/改進(jìn)廠房設(shè)施設(shè)備或系統(tǒng)經(jīng)過正確的調(diào)試/驗(yàn)證后交付投入運(yùn)營(yíng)
Ensures new/improvement facility equipment/system is appropriately commissioned/qualified and then handover for operational use.
?管理廠房設(shè)施工程團(tuán)隊(duì)內(nèi)部的培訓(xùn)，受控文件和圖紙的版本，變更控制，良好文檔實(shí)踐等
Provide governance and management for training, controlled document and drawings, change control, GDP within Facility team
?支持廠房設(shè)施年度預(yù)算管理包括成本節(jié)約項(xiàng)目，監(jiān)視季度花費(fèi)的準(zhǔn)確性，確保公用設(shè)施和設(shè)備系統(tǒng)經(jīng)濟(jì)運(yùn)營(yíng)
Support Facility Annual Operation Cost Plan including cost VIP projects, monitor quarterly cost expense accuracy, ensure Lean operation
?與跨職能團(tuán)隊(duì)合作，支持卓越運(yùn)營(yíng)，支持實(shí)現(xiàn)所有現(xiàn)場(chǎng)目標(biāo)
Collaborate with cross-functional team to support operational excellence and support achievement of all site objectives
?領(lǐng)導(dǎo)項(xiàng)目期間與GMP相關(guān)設(shè)備、設(shè)施和公用事業(yè)系統(tǒng)的調(diào)試與驗(yàn)證等工作。

Leads the C&Q activities associated with GMP related equipment, facility and utility systems during project phase.
?參與所有中國(guó)藥監(jiān)和內(nèi)部對(duì)工廠的檢查與審計(jì)
Participates in all China GMP and internal audits of the manufacturing facilities
?保持質(zhì)量標(biāo)準(zhǔn)，以滿足GMP要求以及公司內(nèi)部關(guān)于設(shè)備和系統(tǒng)的政策
Maintains quality standards to meet GMP requirements and internal company policies with respect to equipment and systems.

要求：

1. 專業(yè)知識(shí)Specific knowledge
?五年以上設(shè)施驗(yàn)證工作經(jīng)驗(yàn) Minimum 5 years experience of validation for Facility system
?在潔凈空調(diào)，潔凈室，潔凈公用設(shè)施系統(tǒng)方面擁有良好的專業(yè)知識(shí) Good knowledge expertise in HVAC, Clean Room and Clean Utility.
?熟悉GMP，熟悉質(zhì)量控制流 Be familiar with GMP and quality control processes
?熟悉設(shè)備驗(yàn)證標(biāo)準(zhǔn)、方法等 Be familiar with Equipment Qualification standard and methodologies
?熟練使用微軟辦公工具處理文檔(Word, Excel) Be familiar with Document handling using Microsoft (Word, Excel)

2. 個(gè)人（領(lǐng)導(dǎo)力）技能Personal and interpersonal skills / Leadership skills
?善于在不同組織間相互溝通和影響的能力 Good at interacting within different functions of the organization.
?關(guān)注于客戶和業(yè)務(wù)Focus on costumer and business
?有良好的團(tuán)隊(duì)精神Good Team player
?誠(chéng)實(shí)正直 Integrity

3. 個(gè)人態(tài)度和心態(tài)Personal attitude and mindset
?以創(chuàng)新和改變?yōu)轵?qū)動(dòng)，保證競(jìng)爭(zhēng)力Drives for innovation and change to ensure competitiveness
?樂觀進(jìn)取的心態(tài)，能夠在拔高的目標(biāo)和時(shí)限要求下敏捷，靈活性工作Can-do mentality, agility & flexibility able to work with stretched goals and deadlines
?愿意將團(tuán)隊(duì)的目標(biāo)放在第一位并與團(tuán)隊(duì)其他人一起朝著目標(biāo)努力Willing to place the goals of the team first and work with others towards these goals
?對(duì)相關(guān)專業(yè)活動(dòng)有高度責(zé)任感Showing a high sense of responsibility regarding professional activities

4. 良好的醫(yī)療器械生產(chǎn)規(guī)范 Good Manufacturing Practice (GMP)
?堅(jiān)持遵守GMP的程序Adhere to applicable GMP and procedures
?報(bào)告事件和偏差Report events and deviations.

5. 安全，健康和環(huán)境績(jī)效Safety, Health and Environment Performance
?堅(jiān)持遵守EHS的程序Adhere to applicable EH&S and procedures
?報(bào)告事故，未遂事件及偏差Reporting of accidents, near miss and deviations
?配合和建議方案提高EHS程序Cooperate on and suggest solutions to improve EH&S
?當(dāng)看到違反EHS規(guī)則的行為要及時(shí)制止，做出適當(dāng)?shù)男袆?dòng)。Act when violation of EH&S rules is observed and stimulate appropriate behavior