職位描述
Responsibilities:
Implement GMP compliance against global GMP standards and China GMP requirement
根據(jù)總部和中國GMP要求，完善GPM的實(shí)施工作
· By assisting P&C lab. Manager to conduct GMP Self- Inspection, and follow-up the implementation action to maintain the global level of GMP compliance.
協(xié)助理化實(shí)驗(yàn)室經(jīng)理實(shí)施GMP自查，跟蹤改進(jìn)實(shí)施計(jì)劃，維護(hù)全球性的GMP實(shí)施水平
· By maintaining the quality system and documentation system to ensure quality system operations in QC meets the regulatory.
通過維護(hù)質(zhì)量體系和文件系統(tǒng)，確保質(zhì)量控制部的質(zhì)量運(yùn)作體系符合法規(guī)要求
Effectuate management of sample distribution and analytical process inspection to ensure timely releases of analytical report to support business need.
實(shí)施樣品分發(fā)和檢驗(yàn)過程的管理職責(zé)，保證檢驗(yàn)報(bào)告及時(shí)放行，以支持業(yè)務(wù)需要。
· By managing working schedule of relative section, to optimize utilization of human resources.
管理相關(guān)領(lǐng)域的工作計(jì)劃，優(yōu)化人員使用效率
· By monitoring the analysis process to push the analytical report issued in reasonable lead time.
監(jiān)控分析過程，督促下屬在合理的分析周期內(nèi)簽發(fā)分析報(bào)告
· By monitoring the timely calibration and maintenance of instrument within working section, ensure keeping in good order.
監(jiān)控工作領(lǐng)域內(nèi)儀器的按時(shí)維護(hù)、校驗(yàn)和保養(yǎng)狀況，以保證儀器設(shè)備的正常使用。
· By monitoring the timely logged, complement of reagents, vessel, reference standard substances, etc. in working section, and ensure sufficient supply.
監(jiān)控工作領(lǐng)域內(nèi)試劑、器皿、標(biāo)準(zhǔn)品等的登錄和補(bǔ)充狀況，以保證正常足量供應(yīng)。
Tutor subordinators to fulfill analysis tasks.
指導(dǎo)下屬完成分析任務(wù)。
· By providing technical support to subordinators if necessary share knowledge and experience within working section.
需要時(shí)向下屬提供技術(shù)支持，分享工作領(lǐng)域內(nèi)的知識(shí)和經(jīng)驗(yàn)。
Complete the assigned routine inspection of sample, issue the reliable analytical report in reasonable lead time.
完成分配的日常檢驗(yàn)樣品，在合理的分析周期內(nèi)簽發(fā)正確的分析報(bào)告。
· By master analytical methods within working section, comply with professional morality and etiquette to ensure reliability and integrity of the analytical data and keeping the excellent capacity of working suitability.
熟練掌握工作領(lǐng)域內(nèi)的分析方法，遵守職業(yè)道德和操守，確保分析數(shù)據(jù)的可靠性和完整性，具備良好的工作適應(yīng)能力。
· By rationalize time allocation, optimizing combination the samples in hand, to keeping the reasonable lead time.
通過工作時(shí)間的合理分配，優(yōu)化待分析樣品的組合，保持合理的 分析周期。
· By form a good working habit to standardize experimental operations.
養(yǎng)成良好的工作習(xí)慣，規(guī)范實(shí)驗(yàn)操作。
· By checking analysis result serious and careful to minimize mistakes and ensure accuracy and reliability of testing figures.
通過認(rèn)真仔細(xì)地復(fù)核分析記錄，盡量減少差錯(cuò)，保證數(shù)據(jù)的準(zhǔn)確性和可靠性。
Implement the maintenance and calibration of assigned instruments
實(shí)施分管儀器的維護(hù)、校驗(yàn)和保養(yǎng)工作。
· By accomplish the calibration and maintenance of assigned instruments, to ensure they are in good order to meet the analytical needs any time.
完成指定儀器的維護(hù)、校驗(yàn)和保養(yǎng)工作，確保儀器設(shè)備隨時(shí)滿足分析需要。
· By keeping the relevant document to trace the calibration, maintenance history and any change of the instruments.
保管相應(yīng)文件，以便追溯儀器的維護(hù)、校驗(yàn)和保養(yǎng)歷史以及所有變更
· By keeping contact with instrument company to obtain the sufficient application technical support.
保持與儀器公司聯(lián)系，以及時(shí)獲得足夠的儀器應(yīng)用的技術(shù)支持。
· By keeping contact with instrument company to obtain the repair service in time.
保持與儀器公司聯(lián)系，以及時(shí)獲得及時(shí)的維修服務(wù)
Implement the analysis method validation.
實(shí)施分析方法驗(yàn)證
· By initiate the defined analysis method validation via planning, executing and reporting process.
通過計(jì)劃、實(shí)施和報(bào)告階段啟動(dòng)指定的分析方法驗(yàn)證工作。
· By organizing the resources to complete yearly method validation plan.
通過組織資源、完成年度方法驗(yàn)證計(jì)劃。
Qualification:
Bachelor of Science Degree or above 理學(xué)士及以上學(xué)位
Pharmacy, Chemistry, Biochemistry and equivalent 藥學(xué)、化學(xué)、生物化學(xué)及相關(guān)學(xué)科
At least 4 years’ experience in Quality Control of major or joint venture Pharma Company.
至少4年在大型或合資制藥企業(yè)質(zhì)量控制工作經(jīng)驗(yàn)
Language skills – English & Chinese 語言能力-英語及國語
