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Carry out daily production activities according to production
instructions and SOPs, including production, cleaning and daily maintenance.
? All operations must
comply with the operation/equipment operating procedures in the relevant area
of responsibility.
? According to
production requirements, the process is constantly monitored to ensure that all
process parameters are within the control range.
? Carry out Dispensing
of API material and Manufacturing activities in area.
? Monitoring and
Control of Production environment and filling the related records.
? To ensure that all
materials are stored under the appropriate conditions as per specification
according to SOPs.
? To fill, check and
sign all production records without delay according to requirement.

? To fill out the
Status labelling of containers, equipments and materials correctly according to
SOPs.
? Strict adherence to
safety, health & environment.
? Carry out operations
as Cipla EHS codes and local norms.
? Dispose the
production waste according to the waste disposal procedure to ensure no
pollution to the environment.
? According to the
requirements of the verification/qualification protocol, carry out the
verification/qualification activities.
? Immediately report
the abnormal situation in the workshop to relevant personnel and fill in
relevant records in a timely manner.
? Receive training
organized by the related department, including job training, GMP, safety,
hygiene, application and production principles. Line clearance during batch /
product change over.
? Carry out the daily
mfg. in clean area to ensure compliance with Cipla quality codes and local
norms.
根據(jù)生產(chǎn)說明和SOP開展日常生產(chǎn)活動，包括生產(chǎn)、清潔和日常維護。
?所有操作必須符合相關責任區(qū)域的操作/設備操作程序。
?根據(jù)生產(chǎn)要求，對工藝進行持續(xù)監(jiān)控，以確保所有工藝參數(shù)都在控制范圍內(nèi)。
?在該地區(qū)開展API材料配送和生產(chǎn)活動。
?監(jiān)控生產(chǎn)環(huán)境并填寫相關記錄。
?確保所有材料按照SOP的規(guī)范在適當?shù)臈l件下儲存。
?根據(jù)要求及時填寫、檢查和簽署所有生產(chǎn)記錄。
?根據(jù)SOP正確填寫容器、設備和材料的狀態(tài)標簽。
?嚴格遵守安全、健康和環(huán)境。
?按照Cipla EHS規(guī)范和當?shù)匾?guī)范進行操作。
處理
根據(jù)廢物處理程序生產(chǎn)廢物，確保沒有對環(huán)境的污染。
?根據(jù)
驗證/資格協(xié)議的要求，執(zhí)行
驗證/鑒定活動。
?立即報告
車間異常情況向相關人員反映并填寫
及時做好相關記錄。
?接受培訓
由相關部門組織，包括崗位培訓、GMP、安全、，
衛(wèi)生、應用和生產(chǎn)原理。
批處理過程中的管線清理/
產(chǎn)品轉(zhuǎn)換。
?開展日常工作
在潔凈區(qū)制造，以確保符合Cipla質(zhì)量規(guī)范和當?shù)貥藴?br>規(guī)范。
原標題：《生產(chǎn)操作人員》