PGS-Wuxi-生产部-技术员Ⅱ

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。

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; 组织协调工序内的生产活动；培训新员工以及定期对岗位员工进行岗位工作考核。

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

参与并带领工序人员进行日常的设备使用、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:

 中专具有5-7年以上制药生产技术经验，制药/化工相关专业；

 大专具有3-5年以上制药生产技术经验，制药/化工相关专业；

 本科，制药/化工相关专业；

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。

In order to complete the production task safely，timely and high-qualitative, the staff should participate in the production of all kinds of registered products in accord with the company’s quality standards, the national drug and food quality standards, safety and labor laws.

A. Production 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.

B. Take part in batch record review. Material receiving and return in SAP system. Responsible for drafting or revising SOP. Organize and coordinate the production activities in the position process; Train new employees and conduct regular assessment position employees.

 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.

C. Product 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.

D. Equipment maintenance and management

 Participate in and lead process personnel Cleaning and maintaining the equipment in the daily operation.

E. Safety 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.

F. New products, new equipment and new technology

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

G. Team spirit.

 Build up an effective team to accomplish team’s targets

H. Personnel 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.

I. Improve production process and efficiency.

 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.

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

K. Cooperate to conduct annual re-validation and new project's validation work.

L. In accordance with the factory's 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.

1. Education Background/ Experience：

 5-7 Years Aseptic process experience with Technical Secondary Diploma.

 3-5Years Aseptic process experience with College Diploma.

 0-2 Years Aseptic process experience bachelor's degree.

 Major in pharmaceutical or chemical engineering.

2. Special Knowledge：

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

3. Skills：

 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.

 
 

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Manufacturing