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