Responsibilities:
工作職責(zé)
? Responsible for Site Quality operations at Cipla China JV Qidong.
? 負(fù)責(zé)西普拉中國(guó)合資企業(yè)啟東的現(xiàn)場(chǎng)質(zhì)量操作。
? Responsible for establishing Pharmaceutical Quality system at Cipla China JV Qidong.
? 負(fù)責(zé)建立西普拉中國(guó)合資啟東的藥品質(zhì)量體系。
? Releasing or rejecting of all Raw materials, packing materials, In process and Finished products at Cipla China JV Qidong.
? 放行或拒收西普拉中國(guó)合資啟東所有原材料、包裝材料、在制品和成品。
? Ensure that the materials tested and released (Raw/Packing/in process/FP) conform to approved specifications and comply with the requirements of the relevant pharmacopoeia, relevant regulations and quality standards.
? 確保被測(cè)試和放行的材料(原料/包裝/過程/成品)符合批準(zhǔn)的規(guī)格符合相關(guān)藥典、相關(guān)法規(guī)和質(zhì)量標(biāo)準(zhǔn)的要求。
? Ensure that the GMP license are acquired, maintained and renewed as per the regulations/requirement.
? 確保GMP許可證的獲取、維護(hù)和更新符合法規(guī)要求。
? Establish and maintain Quality systems as per the CIPLA Global Policy and as per the requirements and regulations of the respective countries for which the products are intended and also as per the regional regulatory requirements.
? 根據(jù)西普拉的全球政策、產(chǎn)品所針對(duì)的國(guó)家的要求和法規(guī)以及區(qū)域法規(guī)要求，建立和維護(hù)質(zhì)量體系。
? Ensure that the drugs are manufactured, tested and stored as per the defined Operating procedures and Guidelines.
? 確保藥品按照規(guī)定的操作程序和指南生產(chǎn)、測(cè)試和儲(chǔ)存。
? Ensure that all Qualifications and Validations are carried out as per the approved Schedule and all the protocols and reports are reviewed and approved.
? 確保所有資質(zhì)和驗(yàn)證都按照批準(zhǔn)的進(jìn)度表進(jìn)行，所有方案和報(bào)告都經(jīng)過審查和批準(zhǔn)。
? Review and approve of change controls, deviations, CAPA and CAPA effectiveness checks.
? 審核和批準(zhǔn)變更控制、偏差、CAPA和CAPA有效性檢查。
? Participate in all internal and external audits and ensure that the site is ready for inspection at any time.
? 參與所有內(nèi)部和外部審計(jì)，確?，F(xiàn)場(chǎng)隨時(shí)準(zhǔn)備接受檢查。
? Ensure that the compliance is provided for all the internal and external audit on time.
? 確保按時(shí)完成所有內(nèi)部和外部審計(jì)。
? Ensure that all the critical suppliers are qualified and approved, Ensure QTA in place for all critical outsourcing GMP activities.
? 確保所有關(guān)鍵供應(yīng)商的合格和批準(zhǔn)，確保所有關(guān)鍵外包GMP活動(dòng)的質(zhì)量協(xié)議到位。
? Ensure that Quality Risk management is designed, followed and reviewed as per the laid down procedures.
? 確保按照制定的程序設(shè)計(jì)、遵循和審核質(zhì)量風(fēng)險(xiǎn)管理。
? To ensure approved Specifications are in place for all Raw materials, packing materials,
work-in-process and Finished products handled at the site.
? 確保在現(xiàn)場(chǎng)處理的所有原材料、包裝材料、在制品和成品的批準(zhǔn)質(zhì)量標(biāo)準(zhǔn)都已到位。
? To ensure that QMS elements such as change control, deviation, CAPA, OOS, OOT, market complaints are closed as per the timelines defined in the SOP.
? 確保QMS要素如變更控制、偏差、CAPA、OOS、OOT、市場(chǎng)投訴等按照SOP中定義的時(shí)間線完成。
? Ensure that the Product Quality review are carried out as per the approved procedure.
? 確保按照批準(zhǔn)的程序進(jìn)行產(chǎn)品質(zhì)量審查。
? Ensure that the process and cleaning employed at the site are validated.
? 確?，F(xiàn)場(chǎng)使用的工藝和清潔方法經(jīng)過驗(yàn)證。
? To approve the procedures, protocols, summary reports, specifications, study reports, hold time reports and other GMP documents executed at the site.
? 批準(zhǔn)在現(xiàn)場(chǎng)執(zhí)行的程序、方案、總結(jié)報(bào)告、質(zhì)量標(biāo)準(zhǔn)、研究報(bào)告、保存時(shí)限報(bào)告和其他GMP文件。
? To ensure that the management review meetings are carried out as per the defined frequency.
? 確保管理評(píng)審會(huì)議按照規(guī)定的頻率進(jìn)行。
? Ensure the Sterility assurance for the sterile injectables manufactured at the site.
? 確?，F(xiàn)場(chǎng)生產(chǎn)的無菌注射劑的無菌保證。
? Ensure that the drugs are manufactured and released as per the requirements of applicable GMP standards.
? 確保藥品按照適用的GMP標(biāo)準(zhǔn)的要求生產(chǎn)和放行。
? Ensured that the Raw materials, packing materials are sourced from the approved vendors and are qualified as per the Cipla vendor qualification policy/procedures throughout the cycle.
? 確保原材料和包裝材料均來自經(jīng)批準(zhǔn)的供應(yīng)商，并在整個(gè)生產(chǎn)周期中按照Cipla供應(yīng)商資格政策/程序進(jìn)行合格。
? To work closely with cross functional team to ensure and maintain the GMP standards at the site.
? 與跨職能團(tuán)隊(duì)密切合作，確保和維護(hù)現(xiàn)場(chǎng)的GMP標(biāo)準(zhǔn)。
? To ensure that the stability of the products is carried out as per the approved schedule.
? 確保產(chǎn)品的穩(wěn)定性按照批準(zhǔn)的時(shí)間表進(jìn)行。
? To ensure that the Environmental monitoring are carried out at the site as per the approved frequency.
? 確保按照批準(zhǔn)的頻率在現(xiàn)場(chǎng)進(jìn)行環(huán)境監(jiān)測(cè)。
? To ensure that the calibration of instruments and equipment are carried out as per the approved frequency.
? 確保儀器和設(shè)備的校準(zhǔn)按照批準(zhǔn)的頻率進(jìn)行。
? To ensure that the equipment/validated as per the defined frequency.
? 確保設(shè)備/驗(yàn)證按照規(guī)定的頻率。
? Ensure Continuous process verification as part of Product Life cycle management.
? 確保持續(xù)工藝驗(yàn)證作為產(chǎn)品生命周期管理的一部分。
? Ensure that the critical utilities such as (Potable water, Purified water, AHU, Compressed air/Gas, WFI, Pure steam) are sampled, qualified, and released as per the defined procedures.
? 確保關(guān)鍵公用設(shè)施，如(飲用水，純化水，空調(diào)機(jī)組，壓縮空氣/氣體，注射用水，純蒸汽)按照規(guī)定的程序進(jìn)行采樣，合格，并釋放。
? Ensure that the Aseptic process validation are executed as per the defined frequency and approved procedure.
? 確保無菌工藝驗(yàn)證按照規(guī)定的頻率和批準(zhǔn)的程序執(zhí)行。
? Ensure that the Personnel working in the critical areas are qualified and monitored as per the defined procedure.
? 確保在關(guān)鍵區(qū)域工作的人員合格，并按照規(guī)定的程序進(jìn)行監(jiān)控。
? Ensure that the Environmental monitoring, WFI, PW, Pure steam, compressed air/Gas are trended.
? 確保環(huán)境監(jiān)測(cè)，WFI, PW，純蒸汽，壓縮空氣/氣體的趨勢(shì)。
? Ensure that all the critical alarms are monitored and trended.
? 確保對(duì)所有緊急告警進(jìn)行監(jiān)控和趨勢(shì)。
? Ensure that all the personnel working in the GMP environment are trained as per their defined Job responsibility.
? 確保所有在GMP環(huán)境下工作的人員按照其定義的工作職責(zé)接受培訓(xùn)。。
? To organize for cause audits as and when required.
? 必要時(shí)組織原因?qū)徍恕?br>? Adhere to the Safety, health and environment policies implemented at the site.
? 遵守在現(xiàn)場(chǎng)實(shí)施的安全、健康和環(huán)境政策。
? To coordinate with regulatory agencies and Regulatory department in addressing, deficiencies, compliance, queries, Notifications if any to the agencies.
? 與監(jiān)管機(jī)構(gòu)和監(jiān)管部門協(xié)調(diào)，解決缺陷，合規(guī)，查詢，如果有任何通知機(jī)構(gòu)。
? Responsible for the release of Finished product manufactured at the site.
? 負(fù)責(zé)現(xiàn)場(chǎng)生產(chǎn)成品的放行。
? Responsible for ensuring that the trainings are carried out as per the approved training matrix.
? 負(fù)責(zé)確保培訓(xùn)按照批準(zhǔn)的培訓(xùn)矩陣進(jìn)行。
? Responsible for assuring mandatory trainings such as GMP, GLP, Data integrity, microbiology, clean room behavior trainings are carried out as per the approved schedule and frequencies.
? 負(fù)責(zé)確保強(qiáng)制性培訓(xùn)，如GMP, GLP，數(shù)據(jù)完整性，微生物學(xué)，潔凈室行為培訓(xùn)按照批準(zhǔn)的時(shí)間表和頻率進(jìn)行。
? Responsible for implementing the Quality culture across the site.
? 負(fù)責(zé)在現(xiàn)場(chǎng)實(shí)施質(zhì)量文化。
? Any other assignment allocated by the Department head.
? 部門主管分配的其他任務(wù)。