宜昌招聘

KEY RESPONSIBILUTIES:

1. Maintain the CSL quality management system in CSL China to ensure corporate, regulatory and GMP/GDP/GSP compliance requirements continue to be met.

2. Ensure that local policies and procedures remain current in line with regulatory, statutory and corporate requirements.

3. Review and Approve functional documentation for the CSL– China regional business operations.

4. Manage, train and mentor Quality staff in the China office(s) on GMP/GDP/GSP, CSL policies, procedures as required

5. Facilitate and administer for CSL China change control process

6. Manage and conduct internal GMP/GDP audit program to monitor the compliance of China business operations

7. Participate in organizational and individual staff training programs in China.

8. Manage the development and training of GMP/GDP/GSP or other Quality training for the CSL China Staff.

9. Maintain internal key relationships with CSL Divisions: CSL Behring (USA, Germany, and Switzerland). Maintain key external relationships with agents/distributors, licensors and partners within China

10. Facilitate the transport release process between manufactures and distributors for shipments into China. Ensure Records of this process are maintained for China operations

11. Managed and conduct GMP/GDP/GSP audits of China supply chain partners, provide audit reports in timely manner, assess audit responses and provide quality advice to maintain regulatory compliance and continuous improvement

12. Manage quality agreements between CSL manufacturers and China Affiliate.

13. Participate in adverse event and product technical complaint investigations on behalf of CSL Behring (as required).

14. Review, risk assess, facilitate the timely investigation, implement CAPA, response, trend and monitor product technical complaints relevant to area of responsibility.

15. Main person responsible for ensuring reporting of customer Product Technical complaints (PTCs) into the Global complaints database in a timely manner and aiding investigation if required

ESSENTIAL CRITERIA:

1. Tertiary Degree qualifications in scientific or related discipline (e.g pharmacy, chemistry, Microbiology, Biochemistry or Chemical Engineering)

2. Excellent working knowledge of QMS, GMP/GDP/GSP (China) principles

3. Minimum three years’ experience in a QA/QC experience (Pharmaceutical or related industry)

4. Highly fluent in Mandarin and English (Written & spoken)

5. Well-developed planning, and time management skills

6. High level organizational and problem-solving skills

7. High level verbal and written communication skills within a cross cultural and functional environment

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集团包括CSL Behring、CSL CSL Plasma、Seqirus 及Research & Development。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产品名称中的“贝林(英文名称‘Behring’)”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，全球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，拥有并运营世界上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
杰特贝林（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。主要产品由CSL Behring杰特贝林公司生产。贝林人血白蛋白自上世纪80年代进入中国,在中国已有20多年的临床安全使用记录。该产品在中国市场占有率排名领先（数据来自IMS Data）。

我们承诺将采用公正、透明的方式选拔和聘用人员，为所有员工提供平等的就业机会和安全健康的工作场所。我们倡导多元化的员工队伍，不论种族、性别、年龄、宗教、残疾和思维方式等的差别，让每一位员工都有机会将自己独特的能力、经验和特点融入到工作中，这有利于促进创新，增强核心竞争力，所以我们非常重视在内部各个级别上实现这种员工队伍的多元化。

CSL全体中国员工将继续秉承CSL集团价值观:卓越表现、创新、诚信、协作、以客户为中心，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：******************.au
电子邮箱：TAChina@cslbehring.com