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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(shuō)明和SOP開(kāi)展日常生產(chǎn)活動(dòng)，包括生產(chǎn)、清潔和日常維護(hù)。
?所有操作必須符合相關(guān)責(zé)任區(qū)域的操作/設(shè)備操作程序。
?根據(jù)生產(chǎn)要求，對(duì)工藝進(jìn)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(kāi)展API材料配送和生產(chǎn)活動(dòng)。
?監(jiān)控生產(chǎn)環(huán)境并填寫相關(guān)記錄。
?確保所有材料按照SOP的規(guī)范在適當(dāng)?shù)臈l件下儲(chǔ)存。
?根據(jù)要求及時(shí)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(shè)備和材料的狀態(tài)標(biāo)簽。
?嚴(yán)格遵守安全、健康和環(huán)境。
?按照Cipla EHS規(guī)范和當(dāng)?shù)匾?guī)范進(jìn)行操作。

處理
根據(jù)廢物處理程序生產(chǎn)廢物，確保沒(méi)有對(duì)環(huán)境的污染。
?根據(jù)
驗(yàn)證/資格協(xié)議的要求，執(zhí)行
驗(yàn)證/鑒定活動(dòng)。
?立即報(bào)告
車間異常情況向相關(guān)人員反映并填寫
及時(shí)做好相關(guān)記錄。
?接受培訓(xùn)
由相關(guān)部門組織，包括崗位培訓(xùn)、GMP、安全、，
衛(wèi)生、應(yīng)用和生產(chǎn)原理。
批處理過(guò)程中的管線清理/
產(chǎn)品轉(zhuǎn)換。
?開(kāi)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(dāng)?shù)貥?biāo)準(zhǔn)
規(guī)范。