长沙招聘

Key Responsibilities主要岗位职责:

1. Provide a highly visible and ‘hands-on’ profile within all operational and functional areas, especially for sterile filling project and sequel sterile manufacturing; liaise with the business centres to drive quality behaviors.

2. To provide business centres with timely effective feedback on operational quality issues.

3. Drive improvements across all operational and functional groups; support the compliance representatives in sterile and/or other area on a daily basis.

4. Review quality event reports and lead / co-ordinate investigations into significant incidents that have resulted in non-conforming sterile products or compliance failures and provide guidance to QC, where required, on the disposition of non-conforming sterile products.

5. Internal document review and/or approval (eg BMRs, CAPAs, Deviation reports, SOPs, change controls).

6. Input into, and review/approval of, commissioning and qualification documents where required

7. Creation of monthly reports on performance of key systems.

8. Provide quality support to site T1/2 performance board meetings.

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

10. Review of, and response to, Quality Alerts

11. Maintain an appropriate level of compliance to GSK’s QMS; review changes to QMS and assess impact to site; drive ‘in place’ and ‘in use’, especially for sterile operation.

12. Participate the site’s internal audit program (level 1 and 2).

13. Host when necessary during external audits (level 3 and 4);

14. Investigate and respond to customer complaints; report metrics.

15. Participate in projects as determined by the Quality Manager.

16. 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. Bachelor or Masters Degree in Chemical Engineering, Science or Pharmaceutical related subjects.

2. At least 3 years experience in a sterile manufacturing environment of pharmaceutical products.

3. Understanding of the Chinese Regulatory Environment and the Regulations for sterile manufacturing and Cephalosporin products

4. Good process understanding knowledge and good analytical skills

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

6. Team player and have a good understanding of other disciplines beyond their own core discipline in order to effectively lead a multi-disciplinary project team.

7. Demonstratable knowledge of sterile commissioning,qualification and trial requirements

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. Excellent knowledge and application of Microsoft Office (in particular Excel)

11. Strong organisational/planning skills

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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