南京招聘

Key Responsibilities主要岗位职责:

1. Actively perform routine monitoring programmes in all production areas across the site whilst employing high standards of Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP)

2. Perform Sterility/Endotoxin/micro limit testing on products and WFI&PW system

3. Perform aseptic filling simulation trials and area process and operator qualification filling trials as an micro-specialist

4. Assist in investigation for micro-lab OOS result

5. Environment monitoring for Isolator and identify the microorganism which separate form EM with API technique

6. Assist in development of methodology for new or modified techniques and preparation or written SOP’s/Methods

7. Maintenance of Aseptic practices and standards

8. Input into, and review of, commissioning and qualification documents where related

9. Monitoring the timely re-validation and maintenance of instrument within working section, ensure keeping in good order.

10. Develop GMP Training Modules across site for sterile manufacturing and provide training as appropriate.

11. Drive improvements across microbiologist group; support the compliance representatives in sterile and/or other area on a daily basis.

12. To ensure that GMP, Quality, Health & Safety are considered in all aspects of role.

Specialised Knowledge 专业知识:

¨ breadth & depth across disciplines or functions; expertise in field required

所需知识的宽度（跨学科），所需知识的深度 （特定学科）

1. University educated with at least 5 years work experience

2. Extensive Aseptic knowledge of manufacture and filling processes gathered only by extended knowledge and experience

3. Understanding of the Chinese Regulatory Environment and the Regulations associated within the area of specialism

4. Be familiar with Autoclave and Isolator operate & validation

5. Be familiar with microorganism identification.

6. Excellent working knowledge of applicable microbial techniques and equipment

7. Good working knowledge of GMP and GLP

8. Experience in problem solving resulting in a demonstratable benefit to the business.

9. Demonstratable competence at training others, on a one to one basis, and larger groups

10. Good communication and interpersonal skill, to include oral communication, writing and listening in English

Desirable:

· Understanding of SFDA and other internal GMP requirements for sterile manufacturing

· Understanding of the product development process including product registration

· Good understanding of OE principles

Demonstrate adding value in the following HPBs: Influence; Enable and drive change; Continuous improvement; Building relationships

GlaxoSmithkline/葛兰素史克
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