QA Specialist
赛诺菲安万特(北京)制药有限公司
- 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:2015-06-11
- 工作地点:北京-大兴区
- 招聘人数:1
- 职位月薪:面议
- 职位类别:药品生产/质量管理
职位描述
JOB PURPOSE
Ensure all the required GMP Quality Systems in the Plant are well followed. Assure the Product Quality in the Warehouse, during Manufacturing and after Release. Check the GMP compliance in the plant. Be the reference person to the Internal Inspections.
KEY TASKS/ACCOUNTABILITIES
1.Manufacture monitoring /Review the Batch Manufacturing / Packing Records, maintain the relevant records/documentation.
2.Ensure the cGMP compliance of the calibration, utilities, systems and production processes (Raw Materials, in Process Controls, Finished Products).
3.Elaborate validation master plan and follow up execution, review validation protocols and reports. Validation execution with related department.
4.Participate in executing the Internal Audits program and following up the agreed corrective actions taken situation.
5.Keep on developing the SOPs according the Global Quality Standard/CGMP and other local requirements together with other department.
6.Execute any other works not mention before come from QA head.
JOB-HOLDER ENTRY REQUIREMENTS
1.Bachelor degree or above, especially in pharmaceutical sciences or similar disciplines.
2.Good English written and reading.
3.Relevant Experience in production or QA at pharmaceutical plant over 3years.
4.Knowledge of requirement of GMP、GLP.
5.Good interpersonal communication skill,think independently and deal with quality issue.
Ensure all the required GMP Quality Systems in the Plant are well followed. Assure the Product Quality in the Warehouse, during Manufacturing and after Release. Check the GMP compliance in the plant. Be the reference person to the Internal Inspections.
KEY TASKS/ACCOUNTABILITIES
1.Manufacture monitoring /Review the Batch Manufacturing / Packing Records, maintain the relevant records/documentation.
2.Ensure the cGMP compliance of the calibration, utilities, systems and production processes (Raw Materials, in Process Controls, Finished Products).
3.Elaborate validation master plan and follow up execution, review validation protocols and reports. Validation execution with related department.
4.Participate in executing the Internal Audits program and following up the agreed corrective actions taken situation.
5.Keep on developing the SOPs according the Global Quality Standard/CGMP and other local requirements together with other department.
6.Execute any other works not mention before come from QA head.
JOB-HOLDER ENTRY REQUIREMENTS
1.Bachelor degree or above, especially in pharmaceutical sciences or similar disciplines.
2.Good English written and reading.
3.Relevant Experience in production or QA at pharmaceutical plant over 3years.
4.Knowledge of requirement of GMP、GLP.
5.Good interpersonal communication skill,think independently and deal with quality issue.
公司介绍
集团概况
尊重:我们认同和尊重员工、患者和合作伙伴的需求及其多样性。我们承诺在互信的基础上开展透明且具有建设性的沟通。
创新:我们鼓励所有的员工和合作伙伴发挥创业精神、探索创新思路。
信心:我们充满自信,恪守原则。我们一心一意、永不气馁,敢于挑战常规。
齐心:我们对我们的行为、我们的员工、我们的患者和我们生存的环境负责。共同的责任让我们走到一起。
正直:我们承诺,坚持最严格的道德操守和质量标准,决不妥协。
赛诺菲安万特(北京)制药有限公司
赛诺菲-安万特(北京)制药有限公司坐落于北京经济技术开发区,占地4万多平方米,现有员工100名左右。公司于2002年12月通过了国家GMP认证,认证范围包括小容量注射剂的分包装,片剂和胶囊的分包装和生产。主要产品分别是亚莫利(片剂1mg,2mg),用于治疗2型糖尿病;瑞泰(片剂5mg),用于治疗高血压;易善复(胶囊和针剂),用于治疗急性和慢性肝病。公司产品于2003年3月开始投放国内市场。
尊重:我们认同和尊重员工、患者和合作伙伴的需求及其多样性。我们承诺在互信的基础上开展透明且具有建设性的沟通。
创新:我们鼓励所有的员工和合作伙伴发挥创业精神、探索创新思路。
信心:我们充满自信,恪守原则。我们一心一意、永不气馁,敢于挑战常规。
齐心:我们对我们的行为、我们的员工、我们的患者和我们生存的环境负责。共同的责任让我们走到一起。
正直:我们承诺,坚持最严格的道德操守和质量标准,决不妥协。
赛诺菲安万特(北京)制药有限公司
赛诺菲-安万特(北京)制药有限公司坐落于北京经济技术开发区,占地4万多平方米,现有员工100名左右。公司于2002年12月通过了国家GMP认证,认证范围包括小容量注射剂的分包装,片剂和胶囊的分包装和生产。主要产品分别是亚莫利(片剂1mg,2mg),用于治疗2型糖尿病;瑞泰(片剂5mg),用于治疗高血压;易善复(胶囊和针剂),用于治疗急性和慢性肝病。公司产品于2003年3月开始投放国内市场。
联系方式
- 公司地址:北京经济技术开发区兴盛街7号
- 邮政编码:100176
- 联系人:人力资源部