长沙 [切换城市] 长沙招聘长沙质量管理/安全防护招聘长沙质量管理/测试工程师(QA/QC工程师)招聘

OQA Specialist- GSKT-天津

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:2014-05-29
  • 工作地点:天津-滨海新区
  • 招聘人数:若干
  • 学历要求:本科
  • 职位月薪:面议
  • 职位类别:质量管理/测试工程师(QA/QC工程师)  

职位描述

Role Purpose

· Ensure the quality assurance of responsible product line, check and control the process according to GMP.

· Coordinator for investigation of deviation, change control and customer complaint.

· Work with Value Stream staff to improve on-line management to mitigate potential quality risk.

Key Accountabilities/Responsibilities

  1. Deal with change control issues of Products and maintenance the database.
  2. Deal with customer complains of product and maintenance the database.
  3. Deal with the quality deviations and return goods of product and maintenance the database as OQA DA/IN investigation responsible person.
  4. Deal with reprocess/rework/repack and return of product.
  5. Monitor in-process control of products’ validity which conducted by VS including manufacturing in process control, packaging process control and packaging quality check.
  6. Support BNRFT project, conduct on-line batch record filling check, to improve right first time rate for BR filling.
  7. Document: Prepare, review and train related SOP and batch record.
  8. BPCS system: change finished product status and do double check on BOM & API system input.
  9. Training the operator, involve qualifying the operator. Have good training skill.
  10. Follow up CAPA of complaint and deviation.
  11. Perform regular GMP inspection of products as per plan.
  12. Coordinator and prepare product annual product review.
  13. Monitor in-process control for product, review updated batch record.
  14. Deal with the OQA related works of new product issues.
  15. Perform other jobs assigned by OQA Section Manager.
  16. As quality representative of BPCS system.

Qualifications/Requirements:

· University graduate or higher in appropriate field.

· Minimum 2 years experience in pharmaceutical manufacturing

· Excellent written and oral communication skills.

· Experience in independent working environment.

· Knowledge on GMP & Quality System.

· SDA Licensed Pharmacist

· Excellent interpersonal and networking skills to establish wide range of contacts across groups.

· Demonstrated initiative and analytical problem solving skill.

· Able to influence at all levels.

· Project management skills.

· Hands on with computers for routine work.

公司介绍

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

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