Quality Officer 质量专员
杰特环亚（上海）医药信息咨询有限公司
- 公司规模：50-150人
- 公司性质：外资(非欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2012-08-23
- 工作地点：上海
- 招聘人数：若干
- 学历要求：本科
- 语言要求：英语精通
- 职位类别：药品生产/质量管理
职位描述
KEY RESPONSIBLILTIES 工作职责
·Maintain the CSL quality management system for the company to ensure regulatory and corporate compliance requirements continue to be met.
·Ensure that local policies and procedures are in line with regulatory, statutory and corporate requirements.
·Review lot release documentation for accuracy for shipments to China
·Assist in the manage supply chain partner assessment programmes and quality agreements for the designated area - Asia Pacific: excluding Japan, Australia and New Zealand where required.
·Maintain the internal GMP audit programme to monitor compliance throughout the CSL Asian business operations
·Review and approve functional documentation for the CSL Asia Pacific China regional business operations.
·Facilitate the transport release process between manufacturers and distributors for Asia Pacific shipments for China. Ensure records of this process are maintained for China.
·Facilitate and administer the CSL Asia Pacific change control process.
·Participate & or facilitate in organisational and individual staff training programmes when required.
·Deliver GMP/GDP training for the CSL Asia Pacific business operations.
·Ensure CSL Asia Pacific controlled documentation system is compliant with CSL corporate and regional Policies and SOPs.
·Maintain key external relationships with agents/distributors, licensors and partners within China
·Maintain internal key relationships with CSL Divisions: CSL Behring (USA, Germany and Switzerland), CSL Biotherapies (Australia and USA).
·Review, risk assess, facilitate the timely investigation of complaints or deviations, implement CAPA, respond, trend and monitor product technical complaints relevant to area of responsibility.
·Assist in the management & execution of internal audits, audit report writing, assess audit responses and provide quality advice to maintain regulatory compliance and continuous improvement.
ESSENTIAL CRITERIA 职位要求
· Bachelor or above degree in a scientific or related discipline (e.g. Pharmacy, Chemistry, Microbiology, Biochemistry or Chemical Engineering)
· Minimum three years experience in a QA / QC experience (Pharmaceutical or related Industry)
· Highly fluent in both written and spoken languages, Mandarin and English
· Skills and Abilities
o Good planning, highly organised and good time management skills
o High level problem solving skills
o High level verbal and written communication skills within a cross functional environment
o Ability to work independently and self motivate.
· Excellent Knowledge of QMS, GMP and GSP (China) / GDP or GLP or GWP
· Strong technical understanding of the relevant regulatory codes.
· Excellent communication skills and ability to influence others.
· Ability to understand and meet customer needs in a helpful way.
· Knowledge and understanding of pharmaceutical manufacturing operations.
· Previous production, quality or R&D experience (Pharmaceutical or related industry).
联系人：单小姐
地址：上海市徐汇区长乐路989号世纪商贸广场2101，2111室
邮编：200031
·Maintain the CSL quality management system for the company to ensure regulatory and corporate compliance requirements continue to be met.
·Ensure that local policies and procedures are in line with regulatory, statutory and corporate requirements.
·Review lot release documentation for accuracy for shipments to China
·Assist in the manage supply chain partner assessment programmes and quality agreements for the designated area - Asia Pacific: excluding Japan, Australia and New Zealand where required.
·Maintain the internal GMP audit programme to monitor compliance throughout the CSL Asian business operations
·Review and approve functional documentation for the CSL Asia Pacific China regional business operations.
·Facilitate the transport release process between manufacturers and distributors for Asia Pacific shipments for China. Ensure records of this process are maintained for China.
·Facilitate and administer the CSL Asia Pacific change control process.
·Participate & or facilitate in organisational and individual staff training programmes when required.
·Deliver GMP/GDP training for the CSL Asia Pacific business operations.
·Ensure CSL Asia Pacific controlled documentation system is compliant with CSL corporate and regional Policies and SOPs.
·Maintain key external relationships with agents/distributors, licensors and partners within China
·Maintain internal key relationships with CSL Divisions: CSL Behring (USA, Germany and Switzerland), CSL Biotherapies (Australia and USA).
·Review, risk assess, facilitate the timely investigation of complaints or deviations, implement CAPA, respond, trend and monitor product technical complaints relevant to area of responsibility.
·Assist in the management & execution of internal audits, audit report writing, assess audit responses and provide quality advice to maintain regulatory compliance and continuous improvement.
ESSENTIAL CRITERIA 职位要求
· Bachelor or above degree in a scientific or related discipline (e.g. Pharmacy, Chemistry, Microbiology, Biochemistry or Chemical Engineering)
· Minimum three years experience in a QA / QC experience (Pharmaceutical or related Industry)
· Highly fluent in both written and spoken languages, Mandarin and English
· Skills and Abilities
o Good planning, highly organised and good time management skills
o High level problem solving skills
o High level verbal and written communication skills within a cross functional environment
o Ability to work independently and self motivate.
· Excellent Knowledge of QMS, GMP and GSP (China) / GDP or GLP or GWP
· Strong technical understanding of the relevant regulatory codes.
· Excellent communication skills and ability to influence others.
· Ability to understand and meet customer needs in a helpful way.
· Knowledge and understanding of pharmaceutical manufacturing operations.
· Previous production, quality or R&D experience (Pharmaceutical or related industry).
联系人：单小姐
地址：上海市徐汇区长乐路989号世纪商贸广场2101，2111室
邮编：200031
公司介绍
CSL集团
CSL(Commonwealth Serum Laboratories的缩写）于1916年成立于澳大利亚，旨在服务因战争而孤立的国家的健康需求。1991年，CSL公司兼并重组后于1994年在澳大利亚证券交易所挂牌上市。此后，CSL成功收购了多家公司，包括CSL Behring。目前CSL集团由两大子公司CSL Behring 和CSL Biotherapies及一家研发公司组成。在过去近100年的历史中，CSL向全球提供疫苗、血浆制品和科技研发等，专注于拯救及改善人类的生命。
CSL Behring
CSL Behring(中文名称杰特贝林)的公司发展历史最早可以追溯到Emil von Behring博士。这位来自德国的医生作为血清疗法的创新者，于1901年赢得了首个诺贝尔生理学和医学奖，而双方的成功合作缔造了当今持续创新的全球公司CSL。CSL的人血白蛋白产品名称“Behring(中文名称‘贝林’)”就是取自Emil von Behring博士的名字，用以纪念他为全人类的健康做出的卓越贡献。
CSL Behring的总部位于美国宾西法尼亚州，三大制造工厂分别位于美国的伊利诺州、瑞士的伯尔尼和德国马堡，而销售和配送中心则遍布全球19个国家，拥有并运营世界最大最先进的血浆采集中心网络之一：CSL Plasma，是全球血浆蛋白生物治疗领域的领导者。
CSL 中国
杰特环亚（上海）医药信息咨询有限公司由CSL Behring公司直接管理,总部设在上海, 在北京、广州、成都、武汉设有分公司。公司主要产品杰特贝林人血白蛋白（包括德国贝林人血白蛋白，美国贝林人血白蛋白及瑞士贝林人血白蛋白）由CSL Behring杰特贝林公司生产。该产品自上世纪80年代进入中国,在中国已有20多年的临床安全使用记录。自2007-2011年该产品在中国市场占有率排名第一（数据来自IMS Data）。
CSL全体中国员工将继续秉承CSL集团价值观:以客户为中心、卓越的表现、创新、诚信、合作,全心全意为广大客户提供优质的产品和服务，为挽救，康复并延长人类寿命做出我们的贡献！
公司网站：http://www.csl.com.au
电子邮箱：chinahr@cslbehring.com
上海总部地址：上海市长乐路989号世纪商贸广场2101,2111室 邮编：200031
北京分公司地址：北京市东城区建国门内大街7号光华长安大厦2座1623室 邮编：100005
广州分公司地址：广州市天河路230号万菱国际中心40楼05-06单元 邮编：510620
成都分公司地址：成都市科华北路62号力宝大厦北楼13层6号 邮编：610041
武汉分公司地址：武汉市汉口解放大道634号新世界中心A座2303室 邮编：430032
CSL(Commonwealth Serum Laboratories的缩写）于1916年成立于澳大利亚，旨在服务因战争而孤立的国家的健康需求。1991年，CSL公司兼并重组后于1994年在澳大利亚证券交易所挂牌上市。此后，CSL成功收购了多家公司，包括CSL Behring。目前CSL集团由两大子公司CSL Behring 和CSL Biotherapies及一家研发公司组成。在过去近100年的历史中，CSL向全球提供疫苗、血浆制品和科技研发等，专注于拯救及改善人类的生命。
CSL Behring
CSL Behring(中文名称杰特贝林)的公司发展历史最早可以追溯到Emil von Behring博士。这位来自德国的医生作为血清疗法的创新者，于1901年赢得了首个诺贝尔生理学和医学奖，而双方的成功合作缔造了当今持续创新的全球公司CSL。CSL的人血白蛋白产品名称“Behring(中文名称‘贝林’)”就是取自Emil von Behring博士的名字，用以纪念他为全人类的健康做出的卓越贡献。
CSL Behring的总部位于美国宾西法尼亚州，三大制造工厂分别位于美国的伊利诺州、瑞士的伯尔尼和德国马堡，而销售和配送中心则遍布全球19个国家，拥有并运营世界最大最先进的血浆采集中心网络之一：CSL Plasma，是全球血浆蛋白生物治疗领域的领导者。
CSL 中国
杰特环亚（上海）医药信息咨询有限公司由CSL Behring公司直接管理,总部设在上海, 在北京、广州、成都、武汉设有分公司。公司主要产品杰特贝林人血白蛋白（包括德国贝林人血白蛋白，美国贝林人血白蛋白及瑞士贝林人血白蛋白）由CSL Behring杰特贝林公司生产。该产品自上世纪80年代进入中国,在中国已有20多年的临床安全使用记录。自2007-2011年该产品在中国市场占有率排名第一（数据来自IMS Data）。
CSL全体中国员工将继续秉承CSL集团价值观:以客户为中心、卓越的表现、创新、诚信、合作,全心全意为广大客户提供优质的产品和服务，为挽救，康复并延长人类寿命做出我们的贡献！
公司网站：http://www.csl.com.au
电子邮箱：chinahr@cslbehring.com
上海总部地址：上海市长乐路989号世纪商贸广场2101,2111室 邮编：200031
北京分公司地址：北京市东城区建国门内大街7号光华长安大厦2座1623室 邮编：100005
广州分公司地址：广州市天河路230号万菱国际中心40楼05-06单元 邮编：510620
成都分公司地址：成都市科华北路62号力宝大厦北楼13层6号 邮编：610041
武汉分公司地址：武汉市汉口解放大道634号新世界中心A座2303室 邮编：430032
联系方式
- Email：chinahr@cslbehring.com