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Qualifications (minimum requirements) 任職資格
Education Background: 教育背景
? 4-yr (BS) Degree or above in IT, automation, Pharmaceuticals Engineering or related field IT、自動化、藥學(xué)、 工程學(xué)或其他相關(guān)領(lǐng)域?qū)W科4 年本科學(xué)士學(xué)位或以上
? Fluent in written and spoken English良好的英語書寫和溝通能力
Professional Experience專業(yè)經(jīng)驗:
? Minimum 3 years of experience in IT, automation or CSV related positions, experience in pharmaceutical industry and quality assurance preferred, experience related to CSV pre-ferred 至少3年IT或自動化相關(guān)職位工作經(jīng)驗，制藥行業(yè)和質(zhì)量保證工作經(jīng)驗優(yōu)先, 計算機(jī)化系統(tǒng)驗證工作經(jīng)驗優(yōu)先
? Good knowledge on regulatory requirements and expectations of cGMP from NMPA and EU especially for IT和automation related part. 熟悉國家食品藥品監(jiān)督管理總局和歐盟法規(guī)要求,尤其是IT和自動化相關(guān)的部分。
? Previous work experience on driving and developing business Intelligence & office auto-mation, especially office digitalization solutions preferred最好有引領(lǐng)和開發(fā)商業(yè)智能和辦公自動化，尤其是辦公數(shù)字化解決方案的工作經(jīng)驗
? Familiar with application of Tableau, RPA, Power Platform, etc.熟練使用Tableau，機(jī)器人流程自動化RPA，低代碼開發(fā)平臺Power Platform等
? Self-motivated, self-learning and innovation mindset 具備較強(qiáng)的內(nèi)驅(qū)力,自我學(xué)習(xí)能力和變革創(chuàng)新意識
? Ability to worked effectively in cross- organizational networks.具有在跨組織的工作網(wǎng)絡(luò)中高效工作的能力。
? Good business understanding across and above site, and ability to integrate specialist knowledge and business perspective. 深入理解工廠內(nèi)部和上游的業(yè)務(wù)，有能力將專業(yè)知識有效運(yùn)用到業(yè)務(wù)中。
? Has demonstrated ability to deliver high quality results and improve process. 具有改進(jìn)工作流程、高質(zhì)量完成工作的能力。
? Good communication skill and be able to convince internal stakeholders on disagreements. 具備良好的溝通能力，當(dāng)有不同意見能夠說服相關(guān)方以達(dá)成一致
Job content工作內(nèi)容描述
Purpose of the Job 職位目標(biāo):
The senior QA engineer of IT is responsible for all IT quality assurance related matters in de-partment scope, ensuring high compliance with cGMP requirements and internal NN proce-dures. Assist manager to make right decision from quality point of view. Support other QA col-leagues with technical knowledge. Support stakeholders when they consult about compliance questions.
The senior QA engineer of IT is responsible for driving and developing business intelligence & office automation, to fulfil the purpose of data based decision-making, FTE release, etc.
The overall success will be measured upon:
1. High efficiency/quality work of process support.
2. Independent capability of process support and problem solving.
3. Good behaviour for high quality mind set, simplicity the process and continuous improve-ment.
Good co-operation and communication with inside/outside department/site stakeholder with across boundary behaviour.
高級IT質(zhì)量保證工程師負(fù)責(zé)部門業(yè)務(wù)范圍的所有IT相關(guān)質(zhì)量保證事務(wù)，以保證所有生產(chǎn)活動和工作流程高度符合cGMP的要求以及諾和諾德內(nèi)部程序。從質(zhì)量的角度協(xié)助經(jīng)理做出正確的決策。向其他質(zhì)量保證工作人員提供專業(yè)技術(shù)知識培訓(xùn)；向其他同事提供合規(guī)相關(guān)問題的咨詢意見。
該高級IT質(zhì)量保證工程師負(fù)責(zé)在質(zhì)量區(qū)域引領(lǐng)和開發(fā)商業(yè)智能和辦公自動化，以順應(yīng)趨勢實(shí)現(xiàn)利用數(shù)據(jù)支持業(yè)務(wù)決策，釋放重復(fù)勞動的勞動力等目的。
工作的成果從以下方面衡量：
1． 高質(zhì)高效地完成流程支持工作
2． 獨(dú)立地完成流程支持工作和解決問題
3． 高度的質(zhì)量意識、良好的行為表現(xiàn)、簡化流程以及持續(xù)改進(jìn)
與各個工作相關(guān)方良好合作和進(jìn)行有效溝通。
Main Job Tasks 崗位職責(zé):
Sr. Validation & IT QA has the responsibility and the authority to: 驗證及IT高級質(zhì)量保證工程師被授權(quán)負(fù)責(zé)以下工作：
Validation & IT QA coordinates and/or supports the actions necessary to achieve planned re-sults and continual improvement of Quality Management System. 驗證及IT系統(tǒng)質(zhì)量保證工程師協(xié)調(diào)并支持必要的活動以達(dá)到預(yù)期的結(jié)果，推動質(zhì)量管理體系的持續(xù)改進(jìn)。
Provide quality and compliance related input and make decisions on quality and compliance related issues. 對質(zhì)量和合規(guī)相關(guān)問題給出建議和意見，并決定處理方法。
Drive and develop business intelligence & office automation, especially implementation of office digitalization solutions in Quality Area.
在質(zhì)量區(qū)域引領(lǐng)和開發(fā)商業(yè)智能和辦公自動化，確保辦公數(shù)字化解決方案的落地。
? Related Validation documents approval, including IT functional and non-functional qualifi-cation for facility and equipment 相關(guān)驗證文件的批準(zhǔn)，包含儀器設(shè)備和設(shè)施的相關(guān)IT功能性和非功能性驗證。
? Establish SOPs for quality related processes and procedures where relevant建立質(zhì)量相關(guān)流程和操作程序的SOP。
? Provide training to employees within and outside of the quality assurance department. 向員工提供質(zhì)量相關(guān)培訓(xùn)。
? Handle and answer internal and external (authority) audits and regulatory affair inquiries. 應(yīng)對內(nèi)、外部審計和檢查，回答法規(guī)事務(wù)調(diào)查和詢問。
? Review and approve operational documents requiring QA approval, including but not lim-ited to: 審核并批準(zhǔn)所有需要QA批準(zhǔn)的操作性文件，包括但不限于：
Standard operating procedure (SOP) 標(biāo)準(zhǔn)操作規(guī)程
Change requests 變更(CR)
IT incident IT事件
IT Periodical System Evaluation IT 系統(tǒng)階段性回顧
Being the Site Core Process SME, responsible for:
Act as One-point of entry for process related issues in the unit
Ensure stable and effective execution of the process.
Monitor compliance and operational performance within in the unit and provide knowledge on process performance e.g., product quality, operational performance, compli-ance performance and equipment/system performance.
Explore and understand the ability, capacity and limitations of the process, equipment and supporting systems.
Ensure that all unit SOPs within the process comply with QMS and are technically and prac-tically workable.
Participate actively in the Process Group work and participate in meetings as agreed.
Ensure awareness in line management in relation to prioritization of Process Group activi-ties, e.g., resource allocation for compliance- and improvement activities
Verify readiness for audit and inspections and be ready for process presentations within own unit and process