工作內(nèi)容CONTENT
1.按照已批準的生產(chǎn)規(guī)程和批記錄進行制劑的生產(chǎn)。
Produce drug product according to approved production procedure and batch production records.
2.及時填寫批生產(chǎn)記錄及相關附加記錄并簽名。
Fill in batch production records and related additional record in time and sign.
3. 及時報告生產(chǎn)偏差，協(xié)助進行關鍵偏差的調(diào)查，發(fā)現(xiàn)問題及時上報生產(chǎn)組長。
Report the production deviations timely, assist the investigation of critical deviations, and report problems to Production Team Leader in time.
4. 確保生產(chǎn)設備設施是清潔合格的，并按照要求進行消毒。
Make sure that production facilities and equipment are cleaning qualified, and disinfect according to the requirements.
5. 協(xié)助進行廠房和設備的維護保養(yǎng)，并完成記錄。
Assist to complete the maintenance of workshop and equipment, and complete the records.
6. 協(xié)助撰寫驗證方案。
Assist to draft validation protocols.
7. 協(xié)助完成新的或經(jīng)過改造的（必要時）生產(chǎn)設施和設備的確認工作。
Assist to execute the qualification of new or modified (when necessary) facilities and equipment.
8. 完成其他相關工作。
Execute other related tasks.
教育背景和任職資格EDUCATION BACKGROUND AND QUALIFICATION
1. 具有高中以上學歷，參加本公司上崗培訓并考試合格。
High school education or above, attended the company’s on-the-job training and passed the examination.
2. 熟悉固體制劑生產(chǎn)流程或具有藥學理論知識。
Familiar with the production process of solid drug product manufacture or have pharmaceutical theoretical knowledge.
3. 經(jīng)培訓后可以熟練操作車間制劑工藝設備。
Be able to operate skillfully formulation process equipment installed at plant after training.
4. 了解GMP法規(guī)。
Understand “Good Manufacturing Practices”.
5. 能吃苦耐勞，服從安排，聽從指揮。
Can bear hardships and stand hard work, obey arrangements and follow commands.
6. 具有至少一年以上口服固體制劑生產(chǎn)經(jīng)驗。
At least 1 year OSD production work experience.