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    更新于 今天

    口服固體制劑生產(chǎn)工程師 (MJ000318)

    8千-1.2萬
    • 蘇州虎丘區(qū)
    • 3-5年
    • 大專
    • 全職
    • 招1人

    職位描述

    固體制劑GMP


    完成口服固體制劑生產(chǎn)區(qū)域的工作。具備持續(xù)改進(jìn)的意識,以提高個人與團隊能力為目標(biāo)。

    Complete work in OSD production area. Have continuous improvement awareness.Have the goal of improving individual and team capabilities.

    具有良好的職業(yè)道德、敬業(yè)精神及團隊協(xié)作精神,工作積極主動、責(zé)任心強。

    Have good professional ethics, professionalism and teamwork spirit, work actively and have a

    strong sense of responsibility.

    1. 一般要求

    General requirement

    ? 積極參與OSD車間的日常工作。

    Actively participate in the daily work of OSD workshop.

    ? 按生產(chǎn)計劃保質(zhì)保量完成生產(chǎn)任務(wù);遵循GMP 規(guī)范的要求保證產(chǎn)品質(zhì)量。

    Finish the production task according to the production plan to ensure the quality and quantity; Follow GMP specification to ensure product quality.

    ? 負(fù)責(zé)固體制劑區(qū)域和設(shè)備的操作和清潔,確保所用設(shè)備保持清潔和完好。

    Responsible for the operation and cleaning of the OSD equipment to ensure that the equipment is kept clean and in good condition.

    ? 遵守公司規(guī)章制度和GMP要求,并及時報告與GMP相背離的現(xiàn)象。

    Comply with company regulations and GMP requirements and report any deviation from GMP.

    ? 遵循EHS 規(guī)范符合環(huán)境保護,員工職業(yè)保護和生產(chǎn)安全。

    In accordance with EHS regulations to comply with environmental protection, employee occupational protection and production safety.

    ? 按照SOP要求及時準(zhǔn)確地填寫生產(chǎn)記錄。

    Fill in the production record timely and accurately according to SOP.

    ? 提出有建設(shè)性的建議并參與提高質(zhì)量,效率,成本以及安全的項目。

    Make constructive suggestions and participate in projects to improve quality, efficiency, cost and safety.

    ? 具有良好的安全意識和行為,以避免安全事故的發(fā)生。

    Good safety awareness and behavior to avoid accidents.

    ? 服從主管安排的工作任務(wù),包括培訓(xùn)等。

    Obey the task assigned by supervisor, including training, etc.

    ? 當(dāng)任何違反公司政策、目標(biāo)或要求的情況發(fā)生時要第一時間通知主管。

    Inform supervisor immediately of any violation of company policy, objectives and requirements.

    2. 主要負(fù)責(zé)的產(chǎn)品技術(shù)工作:

    Mainly responsible for product technology:

    1) 負(fù)責(zé)相關(guān)驗證工作,包括工藝驗證的管理,設(shè)備的再確認(rèn)等

    Responsible for relevant validation work, including process validation management, equipment reconfirmation, etc

    2) 負(fù)責(zé)設(shè)備計算機化系統(tǒng)管理(包括年度回顧、概述、審計追蹤、風(fēng)險評估等)

    Be responsible for equipment computerized system management (including annual review, overview,audit tracking, risk assessment, etc.)

    3) 參與相關(guān)變更發(fā)起、評估、CAPA執(zhí)行

    Participate in relevant change initiation, evaluation and CAPA implementation

    4) 參與相關(guān)偏差的發(fā)起、評估、調(diào)查、CAPA執(zhí)行

    Participate in the initiation, evaluation, investigation and CAPA implementation of relevant deviations

    3、GMP相關(guān)工作:

    GMP related work:

    1) 負(fù)責(zé)生產(chǎn)SOP/WI/SPEC的起草和升版

    Be responsible for drafting and upgrading sop/wi/spec of the production area

    2) 負(fù)責(zé)生產(chǎn)內(nèi)部偏差、變更、新文件的培訓(xùn)

    Be responsible for the training of internal deviations,changes and new documents of the production area

    3) 負(fù)責(zé)生產(chǎn)文檔的管理,文件分發(fā)、回收、歸檔等

    Responsible for production area document management, document distribution, recycling, archiving, etc

    4) 負(fù)責(zé)生產(chǎn)設(shè)備/設(shè)施的計量

    Be responsible for the measurement of production area equipment / facilities

    4、 EHS相關(guān)工作:

    1) 及時發(fā)現(xiàn)包裝安全隱患并及時上報

    Discover and report the potential safety hazards of the packaging area in time

    2) 配合EHS部門完成相關(guān)法規(guī)檢查

    Cooperate with EHS department to complete relevant regulatory inspection

    3) EHS相關(guān)CAPA及時完成并關(guān)閉

    EHS related CAPA shall be completed and closed in time



    Additional Job Description

    ? 大專以上學(xué)歷,藥學(xué)、機電或相關(guān)專業(yè)畢業(yè)

    College degree or above, major in pharmacy, mechatronic or related

    ? 大專學(xué)歷,制藥行業(yè)3年的工作經(jīng)歷

    3 years of working experience in pharmaceutical industry for Junior college graduate.

    ? 良好的GMP知識

    Good knowledge of GMP

    ? 良好的制藥生產(chǎn)知識

    Good knowledge of pharmaceutical production

    ? 良好的EHS知識

    Good knowledge of EHS

    ? 設(shè)備操作動手能力較強

    Strong skill of operating equipment

    ? 普通話

    Mandarin

    ? 較好的數(shù)據(jù)分析能力,能熟練操作使用包括Excel、Word,PowerPoint等軟件的操作。

    Good data analysis ability, skilled in the operation of software including excel, word, PowerPoint and so on.

    ? 具備良好的溝通協(xié)調(diào)、問題解決能力

    Good communication, coordination and problem solving skills



    ???百濟神州全球勝任力

    當(dāng)我們通過以下十二項全球勝任力,展現(xiàn)出 "患者為先"、"無界協(xié)作"、"銳意創(chuàng)新 "和 "追求卓越 "的價值觀時,我們就能幫助全世界更多患者獲得更多負(fù)擔(dān)得起的藥品。

    • 團隊協(xié)作
    • 提供并征求坦誠及可行的反饋
    • 自我認(rèn)知
    • 兼容并蓄
    • 積極主動
    • 開拓精神
    • 持續(xù)學(xué)習(xí)
    • 擁抱變化
    • 結(jié)果導(dǎo)向
    • 分析性思維/數(shù)據(jù)分析
    • 卓越財務(wù)
    • 清晰溝通


    BeiGene Global Competencies

    When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

    • Fosters Teamwork
    • Provides and Solicits Honest and Actionable Feedback
    • Self-Awareness
    • Acts Inclusively
    • Demonstrates Initiative
    • Entrepreneurial Mindset
    • Continuous Learning
    • Embraces Change
    • Results-Oriented
    • Analytical Thinking/Data Analysis
    • Financial Excellence
    • Communicates with Clarity


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    由于百濟神州在全球范圍內(nèi)開展業(yè)務(wù),我們可能需要基于人力資源管理等合理業(yè)務(wù)目的而將您的個人信息發(fā)送和/或存儲在位于您所在國家以外其他國家(例如:美國)的服務(wù)器和數(shù)據(jù)庫中,詳情參見百濟神州《求職者隱私政策》(百濟神州官網(wǎng) - 隱私政策 - 求職者隱私政策)。

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    BeiGene is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity.


    Due to the reasonable business need for human resource management as a result of BeiGene’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeiGene Job Applicant Privacy Policy (BeiGene official website - Privacy Policy - Job Applicant Privacy Policy).


    If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeiGene Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.

    工作地點

    桑田島生物產(chǎn)業(yè)園桑田街218號生物產(chǎn)業(yè)園二期6號樓4樓

    職位發(fā)布者

    夏先生/HR

    立即溝通
    公司Logo百濟神州北京公司標(biāo)簽
    About BeiGene BeiGene is a publically traded(BGNE, NASDAQ), globally focused biopharmaceutical company dedicated to becoming a leader in the discovery and development of innovative, molecularly targeted and immuno-oncology drugs for the treatment of cancer. Our cancer biology platform addresses the importance of tumor-immune system interactions and the value of primary tumor biopsies in developing new cancer models. We have a global team of over 200 individuals, including over 150 scientists and clinicians, and a world-renowned scientific advisory board, with deep scientific talent, extensive pharmaceutical experience, and a commitment to improving the lives of cancer patients around the world. Our clinical pipeline is comprised of novel oral small molecules and monoclonal antibodies(mAb) for cancer, including an anti-PD-1 monoclonal antibody, a best-in-class BTK inhibitor, a RAF dimer inhibitor, a best-in-class PARP inhibitor, and a variety of combination clinical studies. In addition, our robust preclinical programs are expected to generate more small molecule and mAb drugs for clinical development in coming years. For more information, please visit our website at www.beigene.com.
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