宜昌 [切换城市] 宜昌招聘宜昌质量管理/安全防护招聘宜昌质量管理/测试经理(QA/QC经理)招聘

Quality Assurance Manager (职位编号:62615624)

杰特贝林(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(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2021-06-04
  • 工作地点:北京-东城区
  • 招聘人数:1人
  • 工作经验:5-7年经验
  • 学历要求:本科
  • 职位月薪:1-1千/月
  • 职位类别:质量管理/测试经理(QA/QC经理)

职位描述

KEY RESPONSIBILUTIES:

  1. Maintain the CSL quality management system in CSL Asia pacific 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. Support Product Release for all products to ensure the compliance of GMP, GDP standard, company’s requirements, and relevant regulatory requirements. Communication with Regulatory Authorities (NIFDC, BJIDC …) for product related quality events.

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

  5. Manage the development and training of GMP/GDP/GSP or other Quality training for the CSL Asia Pacific – China Staff.

  6. Ensure to implement GMP/GSP/GDP related requirements from local regulations properly, cooperate with relevant stakeholders, either directly (being involved in selection process, support qualification and performance of audits) or through coordination with the concerned other functions (as appropriate)

  7. Facilitate and administer for CSL Asia Pacific –China change control process

  8. Handle Deviation and CAPA Management

  9. 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

  10. Manage quality agreements between CSL Asia Pacific and China Supply chain partners, Maintain internal key relationships with CSL Divisions. Maintain key external relationships with agents/distributors, licensors, and partners within China

  11. Support Oversea Inspection of manufacture site at CSL Behring

  12. Maintain framework for enabling project managed solutions to close Quality gaps to minimize risk to the company

  13. Coordinate the development and implementation of QMS projects.


ESSENTIAL CRITERIA:

  1. Bachelor’s degree or above majored in Biology, Pharmacy, Microorganism, Medicine, or Chemistry in Pharmacy.

  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

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

联系方式

  • Email:TAChina@cslbehring.comKEY
  • 公司地址:地址:span北京市东城区东长安街1号东方广场东方经贸城东1座2层7座