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Job Responsibilities 崗位職責(zé)
1.Responsible for the normal operation, maintenance and improvement of SCM quality system, to ensure the quality management meet the regulations compliance.
負(fù)責(zé)監(jiān)供應(yīng)鏈部門(mén)日常質(zhì)量管理體系的運(yùn)營(yíng)和維護(hù)，確保符合法規(guī)要求;
2.Responsible for the management, tracking of deviation, CAPA, CR, and the OOS related the materials, ensuring the timeliness of quality handling.
負(fù)責(zé)偏差，CAPA及變更，涉及物料的OOS的管理和跟蹤推進(jìn)，確保質(zhì)量事件處理的及時(shí)效性;
3.Participate in and organize the implementations of GMP internal or external audits, and supporting for the warehouse on-site audit reception and subsequent audit response, and tracking of correct of findings after audit.
參與，組織實(shí)施GMP自檢和外部審計(jì),支持倉(cāng)庫(kù)現(xiàn)場(chǎng)的迎審接待及后續(xù)審計(jì)回復(fù)，以及審計(jì)結(jié)束后的缺陷項(xiàng)的整改跟蹤;
4.Responsible for GMP making training plans and maintenance for the department personnel, and the development, coordination, tracking, and completion of training activities in the department, as well as the management of employee training files.
負(fù)責(zé)部門(mén)人員GMP培訓(xùn)計(jì)劃的制定和維護(hù)，及部門(mén)培訓(xùn)工作的開(kāi)展，協(xié)調(diào)，跟蹤，完成培訓(xùn)活動(dòng)，及員工培訓(xùn)檔案管理。;
5.Responsible for drafting, reviewing, training, approval, issuing, archiving recovering of department GMP management documents.
負(fù)責(zé)部門(mén)內(nèi)GMP管理文件的起草，審核，培訓(xùn)，生效，發(fā)放，存檔和回收等;
6.Responsible for numbering, issuing, recovering and archiving of kinds of records.
負(fù)責(zé)各類(lèi)記錄的編號(hào)，發(fā)放，收回和歸檔;
7.Responsible for the verification, calibration and other auxiliary work related to warehouse equipment and facilities, including the drafting and approval of URS and SRA, etc., and cooperate with the ENG department to complete the calibration-related work.
負(fù)責(zé)倉(cāng)庫(kù)設(shè)備設(shè)施等涉及的驗(yàn)證，校準(zhǔn)等相關(guān)輔助性工作,包括URS, SRA的起草及簽批生效等，協(xié)同ENG部門(mén)完成校準(zhǔn)相關(guān)工作;
8.Responsible for the quality management review and analysis within the department.
負(fù)責(zé)部門(mén)內(nèi)部的質(zhì)量管理回顧與分析;
9.Assist in providing relevant records or data required by clients for supply chain management.
協(xié)助提供客戶針對(duì)供應(yīng)鏈管理需要提供的相關(guān)記錄文件或是數(shù)據(jù);
10.Assist in completing other work within the department, equipment procurement requirements and other departmental expenses, purchase application and acceptance, etc.
協(xié)助完成部門(mén)內(nèi)部的其他的工作，設(shè)備的采購(gòu)需求及其他部門(mén)費(fèi)用采購(gòu)申請(qǐng)及驗(yàn)收等;
11.Assist in completing other temporary work arranged by department leaders.
協(xié)助完成部門(mén)領(lǐng)導(dǎo)安排的其他的臨時(shí)性工作。
Job Requirements 崗位要求
1.Bachelor's degree or above in pharmacy or related majors.
藥學(xué)或是相關(guān)專業(yè)本科及以上學(xué)歷；
2.More than 3 years of experience in quality management or on-site supervision and management of pharmaceutical manufacturers, familiar with the basic business processes of warehouses.
有3年以上藥品生產(chǎn)企業(yè)質(zhì)量管理或是現(xiàn)場(chǎng)監(jiān)督管理經(jīng)驗(yàn)，熟悉倉(cāng)庫(kù)基本業(yè)務(wù)流程；
3.Familiar with local GxP guidelines, policies and regulations is a plus.
了解制藥的相關(guān)要求、規(guī)章以及法規(guī)；
4.Familiar with supplier management and material management；Familiar with regulation requirement of warehouse equipment and facilities.
熟悉供應(yīng)商,物料管理管理流程，熟悉倉(cāng)庫(kù)設(shè)備設(shè)施的基于 法規(guī)的要求；
5.Ability to communicate and collaborate across functional groups in completing necessary job requirements.
具有跨組織的溝通協(xié)作能力保證按時(shí)完成工作；
6.CET 4 or CET 6.
英語(yǔ)四六級(jí)證書(shū)。