Job Description:

Rule: Work on Document Control activities either independently as the lead of the document control system or make sure the document managed fits the Quality system

• Work on Document Control activities either independently as the lead of the document control system or with minimal supervision.

• Receive, log, track, and distribute documents in both electronic and paper format for project record maintenance. Version control, update and maintain project document control procedures and record keeping databases.

• Recognize issues, advise and confer with leadership and project team on matters affecting projects related document records, documents and deliverable products.

• Maintain electronic and hard copy filing system for admin related activities

• Be familiar with the TrackWise and Master Control system and know how to operate well.

• Ensure document control activities such as document management, version control and distribution management are executed in a timely fashion and in accordance with contractual requirements.

• Track and maintain documentation preparation, review, signing and approval schedule and status and make sure follows the timeline and meets the project requirements.

• Setup the document control system for the MFG5 that aligned with the Quality system.

• Represent Document Control in project meetings as required.

• Maintains MFG5 template and document module system in confidently

• Manages issuance of document and or tracking numbering systems governed by Document Control or the quality system

• Record Retention

• Serve as the primary liaison to the Quality Assurance and Document Control organizations for the Product Development group. Serve as the Product Development group’s “go-to” expert on document version control management.

• Manage and support Electronic Document Management System activities and assist Product Development users as required

• Dispute, archive, assign, track, keep the record of the logbook

• Manage and keep track of the usage and catalog of the logbooks used in the MFG5

• Other duties as assigned

Qualifications:

Education and Experience:

A Master's Degree from an accredited four-year college or university in Biology, Chemistry, Life Science, Pharmacology, Bio Engineering or a specialty field related to the functions of the Biological Manufacturing; Two (2) years of experience related to the described duties, one (1) year of which must have included responsibility for planning and implementing training programs.

or

A Bachelor's Degree from an accredited four-year college or university in Biology, Chemistry, Life Science, Pharmacology, Bio Engineering or a specialty field related to the functions of the Biological Manufacturing; Three (3) years of experience related to the described duties, one (1) year of which must have included responsibility for planning and implementing training programs.

Skill required:

Microsoft office suite operation computer skills and knowledge

Knowledge of operation of standard office equipment (printer, fax, etc).

Knowledge of clerical and administrative procedures and systems such as filing and record keeping

Knowledge of principles and practices of basic office management.

Other:

Chinese and English communication skills - written and verbal. Level 4 is acceptable, level 6 is preferred.

Planning and organizing

Prioritizing

Problem assessment and problem solving

Can work independently

Information gathering and information monitoring

Attention to detail and accuracy

Flexibility

Adaptability

Customer service orientation

Teamwork.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

上班地址：马山梅梁路108号

我们的使命
我们的使命是转变和加快制药发现、开发及在快速成长的生物制剂领域造福全球患者。
公司介绍
药明生物（WuXi Biologics）是香港上市公司（代码：2269），我们是全球领先的开放式、一体化生物制药能力和技术平台，旗下包括无锡药明康德生物技术股份有限公司、上海药明生物技术有限公司、苏州药明康德检测检验有限责任公司，并在美国和英国设有子公司。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。目前，公司规模达到2500人，有140多位拥有海外高等学位和工作经验的海归科学家，拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验，打造了世界一流的生物药研究、开发及生产团队。
公司官网：http://www.wuxibiologics.com.cn/
地址：江苏省无锡市滨湖区马山梅梁路108号