Ⅰ

Responsibility scope

operation

Conduct aseptic production operation according to the relative Standard Operation Procedure (SOP) and batch record.

Record the logbook and batch record according to the data integrity requirement.

Meet the market need make full use of various resources coordinate and participate in aseptic production and make sure production go smoothly.

part in batch record review. Material receiving and return in SAP system. Responsible for revise and issue SOP.

Comply with Good Manufacturing Practice (GMP) requirements the company headquarter s Pfizer Quality Standards (PQS) requirements. Operate according to the standards operation procedure so that the product quality is effectively guaranteed.

quality control

Ensure production process meet the Current GMP requirements PQS requirements. Operate according to the standards operation procedure so that the product quality is effectively guaranteed.

maintenance and management

Clean and maintain the equipment in the daily operation.

and health

Have safety and health knowledge to ensure the safety of production the staff should ensure the production site clean conform to the requirements and comply with the relevant management measures.

products new equipment and new technology

Participate in and cooperate with management team to finish new product development and new equipment debugging.

spirit.

Build up an effective team to accomplish teams targets

training and development.

Cooperate with management team prepare training procedures and plan to ensure that the staff s get appropriate training before taking the job.

Improve the production efficiency production capacity stability of product quality he should improve and perfect the technology equipment process and so on and meet the developing needs.

with company policies and regulations related to EHS and responsible for department Environment Health Safety (EHS) work.

to conduct annual re-validation and new projects validation work improve production process and efficiency.

accordance with the factorys work system requirements one should be able to adapt to special work schedules such as early mid and night shifts based on the shift schedule.

Job requirements

Background/ Experience

3-5 Years with Technical Secondary Diploma;2-4 Years with College Diploma; Bachelors degree

Major in pharmaceutical or chemical engineering

Knowledge

Pharmaceutical expertise GMP expertise validation knowledge other national drug laws labor law environmental law etc.

Good communication skills and team spirit and ability to analyze and judge;

Good English comprehensive ability and good at using computer and can operate OFFICE software;

Ability to continuously learn and accept new knowledge;

Ability to perform multiple tasks at the same time. Coordination communication skills analytical skills and teamwork ability.

职责明细

目的

为了安全及时保质保量的完成各种生产任务在符合公司质量标准国家药品食品质量标准安全及劳动法规条件下参加各类注册产品的生产

职责范围

一.生产运行

根据相关标准操作规程SOP及批生产记录的要求完成无菌生产工作根据数据完整性要求填写岗位日志及批记录为了满足市场对产品产量和质量的需求充分利用各种资源协调并参与无菌生产使之有序进行

二.参与批记录的审核思爱普系统SAP中物料的领料退料SOP的修改及起草

三.产品质量控制

确保生产过程中各环节符合药品生产质量管理规范GMP要求及公司总部辉瑞质量标准PQS要求所有操作按标准操作规程执行使产品质量得到有效保证

四.设备维护与管理

参与日常的设备使用清洁维护使设备处于有效运行与管理之中

五.安全与卫生

具有安全和卫生相关知识保证生产的安全进行保证生产现场清洁卫生符合国家及公司要求遵守相应的管理措施

六.新产品新设备与新工艺

参与并协助管理团队进行新产品试制和新设备的调试

七.团队精神

为了完成团队共同目标团结其它员工达成共同目标

八.人员培训及发展员工纪律

协助管理人员制定培训规程及计划并通过合适的程序保证员工得到有效的培训

九.改进生产工艺提高效率

提高生产效率发挥生产能力稳定产品质量对工艺设备流程等进行不断的改进与完善满足不断的发展需求

十.遵守公司有关环境健康安全EHS相关政策和规定并完成EHS相关工作进行验证及新验证项目的实施

十一. 按照工厂工作制度要求能根据排班适应早中夜班等特殊工时工作制的作息时间

任职要求

1.教育程度/经验:

中专制药相关专业且具有3-5年制药生产经验

大专制药相关专业且具有2-4年制药生产经验

本科应届毕业生制药相关专业

2.特别知识

制药专业知识 GMP专门知识验证知识其它国家药品法规劳动法环保法等

3.技能

良好的沟通能力和团队精神及分析判断能力

良好的英语综合能力熟练使用计算机并会操作OFFICE办公软件

具有不断学习/接受新知识的能力

具有同时进行并完成多种任务的能力

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process please review our candidate AI-use guidelines available onPfizer Careers.