·
Draw up new, Improvement,
continuous review and upgradation of existing production SOPs and work systems
and to ensure their strict implementation.
新建、改進(jìn)、持續(xù)審查和升級現(xiàn)有的生產(chǎn)sop和工作系統(tǒng)，并確保其嚴(yán)格執(zhí)行。
·
To fill, evaluate
and sign all production records before they are made available to Quality
Assurance Department.
填寫、評估和簽署所有生產(chǎn)記錄，然后提交給質(zhì)保部門。

• Participate in the handling of quality events
  such as deviations, changes, CAPAs, complaints, etc.

參與偏差、變更、CAPA、投訴等質(zhì)量事件的處理。

·
To ensure all
validation, Qualification and Calibrations are done as per schedule and records
are maintained.
確保所有的驗(yàn)證、確認(rèn)和校準(zhǔn)都按照計劃進(jìn)行，并保持記錄。
·
Optimal Cleaning
Management for CNC Area and Clean Area
合理管理CNC區(qū)域與潔凈區(qū)域清潔活動。
·
Collect and collate
production related data, including output, balance rate, quantity of materials
consumed, and other production related statistics.
收集、整理生產(chǎn)相關(guān)數(shù)據(jù)，包括產(chǎn)量、平衡率、物料的消耗數(shù)量等，與生產(chǎn)相關(guān)的數(shù)據(jù)統(tǒng)計。
·
Review BMR and BPR, regularly review the GDP adherence of BMR and
BPR.
審核批生產(chǎn)記錄和批包裝記錄，定期回顧批生產(chǎn)記錄和批包裝記錄的GDP遵守情況。

·
Review the
production auxiliary records that have been used up and submit them to QA for
archiving.
審核使用結(jié)束的生產(chǎn)輔助記錄，并遞交給QA歸檔。
·
Jobs to be handled /
Operate SAP system based on the roles and rights provided in the application.
根據(jù)應(yīng)用程序中提供的角色和權(quán)限，處理/操作SAP系統(tǒng)的工作。
·
Impart training with
respect to Initial (Induction), on the job training, GMP, Safety, Hygiene,
application and principles of production for department personnel according to
the need.
根據(jù)需要對部門人員進(jìn)行入職培訓(xùn)、上崗培訓(xùn)、GMP、安全、衛(wèi)生、應(yīng)用、生產(chǎn)工藝等方面的培訓(xùn)
·
Responsible for
material counts and making timely purchasing requests.
負(fù)責(zé)物料的統(tǒng)計，并及時提出采購需求
·
Participate in
vendor audits in order to procure quality material
參與供應(yīng)商審核，以獲得優(yōu)質(zhì)材料。
·
Retention and destruction of records.
記錄的保存和銷毀。
·
To conduct Risk
analysis of product, system, equipment, item, process as per standard
procedure.
根據(jù)標(biāo)準(zhǔn)程序?qū)Ξa(chǎn)品、系統(tǒng)、設(shè)備、項目、過程進(jìn)行風(fēng)險分析。

·
Ensure proper
planning and execution of the batches in accordance with the plan.
確保正確的計劃和按照計劃生產(chǎn)。
·
Strict adherence to
safety, health & environment.
嚴(yán)格遵守安全、健康和環(huán)境。
·
Perform other duties
as directed by Department head.
執(zhí)行部門總監(jiān)安排的其他職責(zé)。