南京招聘

Job Purpose and Key Responsibilities :

Job Purpose :

Responsible for document management，and site GMP training to ensure comply with regulatory , GMP requirements and GSK Quality standard.

Proposed Job Description:

Key Responsibilities:

1. Be responsible for site GMP document management, including GMP documents related to RA, products/materials, process & SOP etc. to ensure comply with regulatory, GMP requirements and GSK Quality standards.

2. ensure the updated regulatory and Group quality documents to be issued on time.

3. Be responsible for site code number system for production materials to ensure the material code number system implemented exactly .

4. Establish regulatory & GMP training matrix for both site and quality department and ensure the implementation per schedule.

5. Coordinate site compliance training program, e.g QMS

6. . Perform GEMBA in GMP document storage areas periodically , including the storage areas for quality, production , logistic & engineering functions; Ensure to meet GMP and corporate requirements for documentation management. Raise CAPA and report to line supervisor.

7. Perform or be involved in site L1/L2 audits per schedule.

8. Quality performance update in Site Quality Council

9. Be engaged in quality simplifying program, improve quality operation efficiency.

10. Carry out other works assigned by Quality manager

Follow company safety policy

Specialised Knowledge 专业知识:

· education degree and specialit

Bachelor degree or above ,major in pharmaceutics.

· working experiences

At least one year or above quality management experiences

·speciality knowledge/skill

Know GSK quality organization and QMS system.

Be familiar with GSK report system,know about audit system.

Know relative state and regional law, such as GMP.

Be familiar with all company quality standards , procedures and ChP ,USP,EP.

It’s preferred to have basic knowledge of medicine production process , validation and GMP training. Ant to have using capability of quality management tool.

·computer and foreign language level

Fluently use OFFICE software .

Well English reading and speaking skill which is equivalent to CET-6.

·capability requirement

Good job morality, honest, careful, responsible.

High quality sensitivity

Good comprehensively analytical ,communication, association, response and innovation ability.

Good learning skill

Good training and instructing skill. Good ability of report and learning.

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。
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