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更新于 8月19日

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生產主管

8000-12000元

南通啟東市
3-5年
本科
全職
招1人

職位描述

生產質量管理生產計劃管理醫(yī)藥制造

生產現場管理：
·
Improve, continuously review, and upgrade existing
production standard operating procedures and work systems and ensure their
strict implementation. 改進、持續(xù)審查和升級現有的生產標準操作規(guī)程和工作系統(tǒng)，并確保其嚴格執(zhí)行。
·
Prepare and approve instructions related to
production operations, including in-process controls, and ensure their
implementation, if modified. 編制和批準與生產操作相關的指令，包括過程控制，并確保其執(zhí)行（如有修改）。
·
Monitor on-line documentation and timely input of
all operations/activities. 監(jiān)控所有操作/活動的在線文檔和及時輸入。
·
Ensure line clean up during batch/product
changeover. 確保在批次/產品轉換過程中的清場。
·
Direct operators during production when discrepancies occur. 當出現差異時，在生產過程中直接指導操作員。
Train department personnel in initial (onboarding), on-the-job training, GMP, safety,sanitation, application, and production principles as needed. 根據需要對部門人員進行初步（入職）、在職培訓、GMP、安全、衛(wèi)生、應用和生產原則方面的培訓。

生產計劃和過程控制：

·
Schedule commercial production and ensure supply
according to production orders. 根據生產訂單安排商業(yè)生產并確保供應。

·
Ensure proper planning and execution of batches
according to plan. 確保根據計劃正確規(guī)劃和執(zhí)行批次。

·
Ensure that products are produced and stored in
accordance with standard procedures to obtain the required quality. 確保產品按照標準程序生產和儲存，以獲得所需的質量。

·
Verify quantities at all stages of production. 確認所有生產階段的數量。

·
Protects products and materials from spillage and
spoilage. 保護產品和物料，避免受撒料和損壞。

·
Participate in supplier audits to procure quality
materials. Ensures that all materials are stored in proper conditions according
to specifications with orderly lot segregation and inventory rotation. 參與供應商審核，以采購優(yōu)質材料。確保所有材料按照規(guī)范儲存在適當的條件下，并進行有序的批次分離和庫存輪換。

Maintains inventory of
miscellaneous materials required for production. 維護生產所需雜項物料的庫存。

設施監(jiān)測與運行指南：

·
Inspect
the maintenance of the department, premises, and equipment. 檢查部門、場所和設備的維護情況。
·
Ensure
that all verification, qualification and calibration are performed as planned
and records are maintained.確保所有驗證、鑒定和校準按計劃進行，并保存記錄。
·
Operate
the Smart Track software system according to the roles and rights provided in
the application. 根據應用程序中提供的角色和權限操作智能軟件系統(tǒng)。
·
Processes/operates
the Cipdox software system according to the roles and rights provided in the
application. 根據應用程序中提供的角色和權限處理/操作Cipox軟件系統(tǒng)。
·
Process/operate
SAP system jobs according to the roles and rights provided in the application. 根據應用程序中提供的角色和權限處理/操作SAP系統(tǒng)作業(yè)。
Prepare and update
product history files, machine history files. 準備和更新產品歷史文件、機器歷史文件。

質量保證和GMP：

·
Monitor
and control the production environment. 監(jiān)控生產環(huán)境。
·
Strictly
comply with safety, health, and environmental regulations. 嚴格遵守安全、健康和環(huán)境法規(guī)。
·
Perform
risk analysis of products, systems, equipment, projects, and processes in
accordance with standard procedures. 根據標準程序對產品、系統(tǒng)、設備、項目和流程進行風險分析。
·
Complete,
evaluate, and sign all production records prior to providing them to Quality
Assurance. 在將所有生產記錄提供給質量保證部之前，完成、評估并簽署這些記錄。
·
Document
all changes through change control procedures in consultation with Quality
Assurance. 與質量保證部協商，通過變更控制程序記錄所有變更。
·
Investigate,
document & report to QA any issues that may adversely affect quality of the
material/product, such as damage to containers, etc. 調查、記錄并向QA報告任何可能對材料/產品質量產生不利影響的問題，如容器損壞等。
·
Monitor
for compliance with cGMP requirements and investigate factors that may affect
product quality. 監(jiān)測是否符合cGMP要求，并調查可能影響產品質量的因素。
·
Ensure
that cleaning procedures follow cGMP requirements and that they are strictly
enforced. 確保清潔程序符合cGMP要求并得到嚴格執(zhí)行。
Record retention and
destruction. 記錄保存和銷毀。