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崗位職責(zé)：
? 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，倉庫)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.
任職資格：
1.5 年以上醫(yī)療行業(yè)工作經(jīng)驗(yàn)
More than 5 year working experiences in medical device or healthcare industry
5年以上跨國(guó)公司工作經(jīng)驗(yàn)(優(yōu)先項(xiàng))
More than 5 year working experiences in MNC is preferred
2.語言 LANGUAGES:
能用中英文流利的書寫和交流 Fluent in written and spoken Chinese/English
專業(yè)系統(tǒng) SPECIFIC SYSTEMS:
? 機(jī)電相關(guān)專業(yè) Mechanical/Electrical
? 或?qū)嶒?yàn)室相關(guān)專業(yè) Laboratory
3. 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
4. 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
5. 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.
6. 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