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
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計劃, 監督、協助其他主管完成各自的培訓任務
2. Be in charge of GMP management of Eng. Dept. and ensure the development of Eng. GMP in order and standard.
負責工程部GMP管理工作，確保工程部GMP工作有序、規范地進行
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.
負責生產設備、動力設施設計安裝確認和操作確認工作編制設計，安裝確認和操作確認方案，協調工程部各主管按方
案完成相關數據
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，與國外廠商聯系，取得解決有關設備技術問題方面的指導性意見,做到生產一線的技術支持
5. Be in charge of CAR application .
負責公司固定資產申請流轉
6. Be in charge of inquiry, analysis and justification of the imported and local equipment in the early period of purchasing.
進口及國產生產設備前期調研報價，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.
跟蹤進口設備的到貨情況，負責將試車材料寄給設備供應商，聯系相關人員完成設備工廠驗收測試并得到報告
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.
負責國產、進口新制藥設備的安裝、調試、試運行、驗證，進行進度協調，協助外國專家搞好安裝調試，并出具驗證報告
9. Complete other assignments given by superior
完成領導其他交辦任務
Qualification Requirements
崗位要求
1. 2 years or above work experience of equipment management in pharmaceutical plant
二年以上藥廠設備管理工作經驗
2. Familiar with GMP requirements for equipment, instrument and process.
熟悉藥廠GMP對設備、儀表和工藝的要求
3. Bachelor degree or above, major in Mechanical Engineering, Equipment or Instrument
具有機械、設備、儀表等工科類大學本科以上
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.
了解各類生產設備、動力設備及其它現場設備
7. Knowledge of GMP, EHS
理解GMP規范，了解EHS知識
8. Ability of people management
具備有相關的管理領導能力
9. Ability of planning spare parts according to the importance of equipment
具備根據設備的重要性，提出備件計劃的能力
10. Ability to use MS Office
具備使用辦公室軟件的能力
