Senior Manager, Quality Assurance Release (职位编号:59145525)
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:2020-12-27
- 工作地点:武汉
- 招聘人数:1人
- 工作经验:10年以上经验
- 学历要求:本科
- 职位月薪:1-1千/月
- 职位类别:药品生产/质量管理
职位描述
KEY RESPONSIBILUTIES:
Establish the strategic direction of the Quality Assurance functional area with a focus on continual improvement and compliance.
Provide Leadership to maintain a business wide culture of quality and work collaboratively to set quality strategic direction.
Ensure an appropriate work force planning (5 years ahead) for the department. Manage the resource requirements and budget for the Quality Assurance function to optimize productivity and compliance.
Direct responsibility for core quality systems:
Process Release and rejection process
Deviation and CAPA Management
Product Recall
Quality Oversight of Manufacturing Operations
Actively support and participate in Quality system improvements, some of which may be led by others
Ensure efficient communication of required information to all appropriate customers. Escalate critical issues to the Head of Quality.
Maintain, assess and communicate to the business the KPIs from within the release, deviation/investigation, Operational groups to ensure the effectiveness of their systems.
Develop staff through training, education and execution of development plans to ensure employees are appropriately trained to execute their jobs and develop their behaviours, attitudes and competencies required to optimize their productivity and contribution.
Liaise closely with key departments to ensure smooth execution of the processes.
Take other tasks and duties as assigned by the company.
ESSENTIAL CRITERIA:
Tertiary qualifications in Pharmaceutical, Biological Sciences, Biotechnology, Engineering or Food Science and Technology.
Minimum 10 years’ experience cGMP regulated environment
Strong orientation for quality systems and methodologies to improve production outcomes
Strong ability to build and maintain relationships with internal/external stakeholders.
Understanding of manufacturing, quality control and quality assurance systems including
strong working knowledge of GMP requirements
Highly developed organisational and problem-solving skills.
Ability to work independently and as part of a team.
Demonstrated Leadership capabilities.
A flexible and adaptable approach.
A strong dedication to the job combined with a willingness for self-development.
Demonstrated good work ethic and attitude.
Ability to achieve project objectives within tight timeframes and to perform in a high-pressure environment
职能类别:药品生产/质量管理
公司介绍
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