Documentation Control Specialist-BIO-广东-深圳
葛兰素史克(中国)处方药事业部
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-03-04
- 工作地点:深圳
- 招聘人数:若干
- 职位类别:生物工程/生物制药
职位描述
Scope /Key Accountabilities
1. Support to management 提供管理支持 Accompany the mgt team and provide technical expertise in front of JV management, external authorities, suppliers, internal and external auditors as appropriate
- Ensure that all relevant information relating to activities within your scope are tracked, captured and forwarded in due time to your supervisor.
- Understand how your activities contribute to your department’s strategy
Provide detailed information to help prepare budgets, projects, etc… Generate purchase requests. You may neither authorize purchase requests, purchase orders nor payment orders.
Actively collaborate with other departments. Seek for the voice of your customer.
Understand risks generated within your department. Report all risks and incidents to your supervisor.
Provide input to your manager or supervisor for SOPs, IEFs, … writing.
Perform the following operations.
· Develop document management system, define written procedures for preparing, revising, reviewing, approving, distributing, storage, archival, retrieval and destruction of documents.
· Coordinate the activities of document control, including document distribution and retrieval, reviewing and proof-reading controlled documents; update electronic document directories, etc. Ensure that only the approved current documents will be distributed and used. Further, ensure that withdrawn and out-of-dates documents shall not be present at work site, except those maintained in archives for reference purposes.
· Track and control distributed documents. Provide documentation related information to relevant personnel in time, ensure that distributed documents will be reviewed periodically and updated in time.
· Coordinate the activities of document change to ensure the change is effective and in a timely manner.
· Manage the electronic and hard copies for controlled documents.
· Manage the meeting minutes of QA department or QA involved.
Assist with auditors to perform audit of documentation system to confirm compliance with controlled procedures
· Provide document support for other department during inspection, validation and audit, etc.
· Manage QA systems with respect to issue of code numbers for materials and manufactured lots
· Coordinate a team of site document coordinators
· Coordinate the compilation and verification of completed batch records.
For all the above operations
· Learn and follow SOPs. Participate to the elaboration of SOPs & forms.
· Follow iMS standards : record all activities accurately and on time, report all events that are not aligned with the SOP.
· Acquire and demonstrate a sound process knowledge (advantages, risks, parameters, limits, alternatives ..). Continuously seek to improve the processes. Propose KPIs to measure improvements.
· Participate to the validation of processes, methods and equipment.
· Apply incident, CAPA and change control processes.
· Ensure Environmental, Health and Safety habits are in place.
3. People and team culture 人员和团队建设
Promote a culture in line with Shenzhen GlaxoSmithKline Neptunus Biologicals’ core values :
Passion: I am motivated by what I do. It fulfills me.
Empowerment: I have the power to take decisions and I am trusted to do so.
Collaboration 团队合作 : My team is made up of all the people in the company.
Integrity 正直诚信 : I respect people, my company and the environment. I shall not use the company’s assets to make personal profit. .
Quality 质量第一 : I am responsible for the quality of my work. I understand what I do. There is always a better way to do things; I must find it.
申请资格 / 职位要求 At least a University degree in Biological/Chemistry or related science discipline · Experience with GMPdocumentation and good documentation practices
· Knowledge ofGMPand guidelines.
· Have very good attention to details
· Strong communication skills and ability to work with others in a positive and collaborative manner.
· Ability to utilize multiple word-processing and database applications including MS Office applications Word, Excel, as well as Adobe Acrobat, etc.
· Works under minimal supervision
公司介绍
作为世界领先的制药业巨擘,葛兰素史克公司秉承以研究开发为基础的一贯理念,凭藉公司本身的技术潜力和资源优势,在当今瞬息万变的医疗保健领域保持强劲的增长势头。
葛兰素史克公司,由葛兰素威康和史克必成强强联合,于2000年12月成立。两家公司的历史均可追溯至19世纪中叶,各自在一个多世纪的不断创新和数次合并中,在医药领域都确立了世界级的领先地位。两个制药巨人的成功合并,为葛兰素史克成为行业中无可争议的领导者奠定了基础,并在全球药品市场中占据有7%的份额。
葛兰素史克公司总部设在英国,以美国为业务营运中心,在抗感染、中枢神经系统、呼吸和胃肠道/代谢四大医疗领域代表当今世界的最高水平,在疫苗领域雄居行业榜首。此外,公司在消费保健领域也居世界领先地位,主要产品包括非处方药、口腔护理品和营养保健饮料。2006年公司在全球的销售总额达232亿英镑。目前,公司在全球拥有10万余名既掌握专业技能又有奉献精神的出色员工。
全球研发中心有1万6千科学家和技术人员分布在全球许多国家。为进一步推动研发全球化,葛兰素史克(GSK)中国研发中心于2007年6月成立。中心将侧重于神经退行性病变的研究,目标是为多发性硬化病、帕金森病和阿尔茨海默氏病等严重疾病开发新药。中国研发中心将发展成有1000多科学家和技术人员的全球研发中心。中心将以科学研究为基础(science-driven),通过生物学,化学以及最新技术,创新开发新的治疗手段。中国研发中心将最终引领GSK在这一领域从识别药物靶标到后期临床研究的全球研发活动,并在中国和其他研究机构密切合作。GSK中国研发中心计划在未来10年内成长为GSK的大型研发中心之一。
更多信息请访问我们的网站:www.gsk.com or www.gskchina.com
联系方式
- 公司网站:http://www.gsk.com
- 公司地址:上海市西藏中路168号都市总部大楼6楼
- 邮政编码:200001