職位描述
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職位職能:
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職位描述:
Responsibilities
工作職責(zé)
1. Make up yearly training plan of Engineering Department. Monitor and coordinate other supervisors to implement their training tasks.
制定工程部年度培訓(xùn)計(jì)劃, 監(jiān)督、協(xié)助其他主管完成各自的培訓(xùn)任務(wù)
2. Be in charge of GMP management of Eng. Dept. and ensure the development of Eng. GMP in order and standard.
負(fù)責(zé)工程部GMP管理工作，確保工程部GMP工作有序、規(guī)范地進(jìn)行
3. Be in charge of DQ/ IQ/OQ of production equipment and facilities. Work out protocol of DQ/IQ/OQ of each equipment or facility. Coordinate relevant supervisor of Eng. Department to finish data of protocol.
負(fù)責(zé)生產(chǎn)設(shè)備、動力設(shè)施設(shè)計(jì)安裝確認(rèn)和操作確認(rèn)工作編制設(shè)計(jì)，安裝確認(rèn)和操作確認(rèn)方案，協(xié)調(diào)工程部各主管按方
案完成相關(guān)數(shù)據(jù)
4. Draft the foreign oriented corresponding and communicate with the service depts. of the equipment suppliers from outside China for advice or instruction to solve the problems with the relevant machine. Technical support to the first line in the maintenance team
起草工程部的對外電文，與國外廠商聯(lián)系，取得解決有關(guān)設(shè)備技術(shù)問題方面的指導(dǎo)性意見,做到生產(chǎn)一線的技術(shù)支持
5. Be in charge of CAR application .
負(fù)責(zé)公司固定資產(chǎn)申請流轉(zhuǎn)
6. Be in charge of inquiry, analysis and justification of the imported and local equipment in the early period of purchasing.
進(jìn)口及國產(chǎn)生產(chǎn)設(shè)備前期調(diào)研報價，分析及申請理由
7. Follow up imported equipment delivery condition, be in charge of sending testing samples to supplier for test, and communicate the relevant persons to finish Factory Acceptance Test before equipment delivery and get test report.
跟蹤進(jìn)口設(shè)備的到貨情況，負(fù)責(zé)將試車材料寄給設(shè)備供應(yīng)商，聯(lián)系相關(guān)人員完成設(shè)備工廠驗(yàn)收測試并得到報告
8. Be in Charge of installation, debugging and adjustment, trial and validation of new local-made and imported pharmaceutical equipment. Coordinate the progress schedule, and assist foreign experts to carry on the installation, debugging and adjustment of equipment and finish qualification report.
負(fù)責(zé)國產(chǎn)、進(jìn)口新制藥設(shè)備的安裝、調(diào)試、試運(yùn)行、驗(yàn)證，進(jìn)行進(jìn)度協(xié)調(diào)，協(xié)助外國專家搞好安裝調(diào)試，并出具驗(yàn)證報告
9. Complete other assignments given by superior
完成領(lǐng)導(dǎo)其他交辦任務(wù)
Qualification Requirements
崗位要求
1. 2 years or above work experience of equipment management in pharmaceutical plant
二年以上藥廠設(shè)備管理工作經(jīng)驗(yàn)
2. Familiar with GMP requirements for equipment, instrument and process.
熟悉藥廠GMP對設(shè)備、儀表和工藝的要求
3. Bachelor degree or above, major in Mechanical Engineering, Equipment or Instrument
具有機(jī)械、設(shè)備、儀表等工科類大學(xué)本科以上
4.CET- 4 or above, have an excellent ability to listen, speak, read and write in both English and Chinese
英語四級或以上,具有良好的中英文聽說讀寫能力
5. Knowledge of IQ/OQ documentation
了解IQ/OQ文檔編輯
6. Knowledge of all kinds of manufacturing equipment, utility equipment and other equipment.
了解各類生產(chǎn)設(shè)備、動力設(shè)備及其它現(xiàn)場設(shè)備
7. Knowledge of GMP, EHS
理解GMP規(guī)范，了解EHS知識
8. Ability of people management
具備有相關(guān)的管理領(lǐng)導(dǎo)能力
9. Ability of planning spare parts according to the importance of equipment
具備根據(jù)設(shè)備的重要性，提出備件計(jì)劃的能力
10. Ability to use MS Office
具備使用辦公室軟件的能力
