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工作內(nèi)容：
1.法規(guī)的符合性Compliance with regulations
1.1.學(xué)習(xí)國家藥品法律、法規(guī)，以指導(dǎo)質(zhì)量管理工作，保障GMP生產(chǎn)部門的各項(xiàng)工作符合國家相關(guān)法規(guī)。
Learn national drug laws and regulations to guide quality management and ensure that the work of GMP production department complies with relevant national laws and regulations.
2.廠房、設(shè)施、設(shè)備Buildings、Facilities、Equipment
2.1.負(fù)責(zé)GMP廠房、設(shè)施設(shè)備及其相關(guān)記錄的日常檢查和管理工作，保證其可以正常運(yùn)行并且滿足GMP生產(chǎn)需求。
Responsible for the daily inspection and management of GMP factories, facilities, equipment, and related records to ensure their normal operation and meet GMP production requirements.
2.2.監(jiān)督純化水系統(tǒng)的管理，負(fù)責(zé)對工藝用水的生產(chǎn)進(jìn)行檢查，審核相關(guān)記錄。
Supervise the management of the purified water system, responsible for inspecting the production of process water and reviewing relevant records.
2.3.監(jiān)督潔凈區(qū)空調(diào)系統(tǒng)的管理，負(fù)責(zé)潔凈區(qū)環(huán)境監(jiān)控的跟蹤和相關(guān)記錄的審核。
Supervise the management of HVAC. Responsible for monitoring the clean area environment and auditing the related records.
2.4.負(fù)責(zé)害蟲控制執(zhí)行的監(jiān)督和記錄的審核。
Responsible for supervising the implementation of pest control and reviewing the record regularly.
3. 計(jì)量器具管理Management of the Measuring Instrument
3.1.負(fù)責(zé)監(jiān)督計(jì)量器具依據(jù)國家法規(guī)和相關(guān)SOP完成計(jì)量器具的年度校準(zhǔn)計(jì)劃，計(jì)量器具分類評估。
Responsible for supervising the completion of the annual calibration plan and classification evaluation of measuring instruments in accordance with national regulations and relevant SOPs.
3.2.確保儀器儀表的定期校準(zhǔn)工作，簽發(fā)計(jì)量合格標(biāo)簽，確保校準(zhǔn)證書在有效期內(nèi)，將計(jì)量證書歸檔保存。
Ensure periodic calibration of instruments and meters, Issue metrological labels,Ensure the calibration certificate is valid, Certificate of metrological filing.
4.驗(yàn)證管理Validaiton Management
4.1.審核GMP年度驗(yàn)證總計(jì)劃，監(jiān)督生產(chǎn)部門驗(yàn)證計(jì)劃執(zhí)行情況。
Review the GMP annual validation master plan and supervise the implementation of the validation plan by the production department.
4.2.參與GMP制劑生產(chǎn)部門驗(yàn)證方案、記錄和驗(yàn)證報(bào)告的審核，在驗(yàn)證完成后進(jìn)行歸檔保存。
Participate in the review of GMP DP production department validation plans, records, and validation reports, and archive and preserve them after the validation is completed.
4.3.監(jiān)督檢查在驗(yàn)證實(shí)施中的偏差及整改措施。
Supervise and check the implementation of the deviation and corrective measures in validation.
5.物料及供應(yīng)商管理Material management
5.1. 負(fù)責(zé)供應(yīng)商審計(jì)工作，收集供應(yīng)商資質(zhì)資料、問卷，起草審計(jì)報(bào)告，維護(hù)供應(yīng)商清單，確保物料的供應(yīng)商均經(jīng)過審計(jì)和批準(zhǔn)。
Responsible for supplier audit, collecting the supplier qualification material, questionnaire, preparing the supplier audit report, maintaining the supplier list,ensure material suppliers are audited and approved.
5.2. 監(jiān)督物料的入庫、儲(chǔ)存和出庫管理，審核物料管理記錄并完成物料的放行, 監(jiān)督不合格物料管理以及特殊物料管理。
Supervise material entry, storage and exit management, review material management records and complete material release, supervise nonconforming material management and special material management.
5.3. 發(fā)放物料代碼
Issue the material code.
6. 制劑產(chǎn)品臨床標(biāo)簽Clinical Labeling of DP
6.1. 負(fù)責(zé)標(biāo)簽?zāi)０宓膶徍伺鷾?zhǔn)，簽署 臨床標(biāo)簽?zāi)０鍖徟恚_保標(biāo)簽內(nèi)容符合國家法規(guī)及相關(guān)SOP的要求。
Responsible for the review and approval of the label template, sign the Review and Approval Form of Clinical Label Template, and ensure that the label content conforms to the national regulations and related SOP requirements.
6.2. 負(fù)責(zé)臨床產(chǎn)品標(biāo)簽的訂購/打印及檢查放行。
Responsible for clinical product label ordering/printing and inspection release.
6.3. 負(fù)責(zé)QA條碼打印機(jī)的使用、清潔維護(hù)管理。
Responsible for the use, cleaning, maintenance and management of QA barcode printers .
7. 項(xiàng)目管理Project Management
7.1. 審核生產(chǎn)前的主批生產(chǎn)記錄及生產(chǎn)后執(zhí)行批記錄。
Review the master batch records and the execution batch records.
7.2. 負(fù)責(zé)監(jiān)督產(chǎn)品從物料進(jìn)入生產(chǎn)工藝之后的生產(chǎn)、包裝和發(fā)貨的全過程。
Responsible for supervising the whole process of production, packaging and delivery of products from the raw material into the production process.
7.3. 負(fù)責(zé)生產(chǎn)過程中的清場放行檢查，物料取樣后的清場放行檢查。
Responsible for clearance release inspection during production process and clearance release inspection after material sampling
7.4. 負(fù)責(zé)項(xiàng)目清潔確認(rèn)的審核批準(zhǔn)，配合相關(guān)部門進(jìn)行清潔確認(rèn)工作, 放行已清潔合格的設(shè)備。
Responsible for the reviewing and approval of the project cleaning verification, and cooperate with relevant departments for cleaning verification, release clean and qualified equipment.
8. 負(fù)責(zé)監(jiān)督制劑生產(chǎn)部門使用記錄的發(fā)放和回收。
Responsible for supervising the release and recovery of the use records of the DP production department.
9. 參與工作相關(guān)的偏差、變更控制、投訴等質(zhì)量事件的調(diào)查。
Participate in the investigation of work-related deviations, change control, complaints and other quality incidents.
10. 參與GMP制劑車間、設(shè)備間及庫房的日常巡檢工作。
Participate in the routine inspection of GMP DP workshop, equipment room and warehouse.
11. 完成本部門領(lǐng)導(dǎo)臨時(shí)安排的工作。
Complete other tasks arrangements by department head.
教育背景及任職資格
1.教育背景：化學(xué)、應(yīng)用化學(xué)、藥學(xué)或相關(guān)專業(yè)本科或大專及以上學(xué)歷
Education Background：Bachelor degree or college degree above in chemistry, applied chemistry, pharmacy or other related fields.
2.經(jīng)驗(yàn)：應(yīng)當(dāng)至少具有藥學(xué)或相關(guān)專業(yè)本科或大專學(xué)歷（或中級(jí)專業(yè)技術(shù)職稱或執(zhí)業(yè)藥師資格）。本科學(xué)歷，具有至少1年從事藥品生產(chǎn)和質(zhì)量管理的實(shí)踐經(jīng)驗(yàn)，接受過與所生產(chǎn)產(chǎn)品相關(guān)的專業(yè)知識(shí)培訓(xùn)。大專學(xué)歷（或中級(jí)專業(yè)技術(shù)職稱或執(zhí)業(yè)藥師資格），具有至少2年從事藥品生產(chǎn)和質(zhì)量管理的實(shí)踐經(jīng)驗(yàn)，接受過與所生產(chǎn)產(chǎn)品相關(guān)的專業(yè)知識(shí)培訓(xùn)。
Experience: A bachelor degree or college degree above in pharmacy other related field(or qualified midlevel with the title in professional or licensed pharmacist ), bachelor degree ,more than 1 years of experience in drug production and quality management, trained in professional knowledge related to the products produce. college degree (or qualified midlevel with the title in professional or licensed pharmacist ), more than 2 years of experience in drug production and quality management, trained in professional knowledge related to the products produce.
3 技能技巧：具有一定的專業(yè)英語讀寫能力。
Skills: have a certain ability to read and write in professional English.