QC Senior Manager
百济神州(北京)生物科技有限公司
- 公司规模:5000-10000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:2019-10-11
- 工作地点:北京
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:招1人
- 语言要求:不限
- 职位类别:生物工程/生物制药
职位描述
Build strong quality control organization related Chemistry GMP activities.
Commitment to Quality and Compliance, operate at the highest global standards, hominization with Global quality standard to achieve continual improvement
Responsible for technical assessment for a contract lab to support GMP operation, support the Contract lab oversight.
To approve COA/ADS, as the sees fit, starting materials, packaging materials, intermediate, bulk and finished products as the delegate of Head of Quality;
To ensure that all necessary testing is carried out and the associated records evaluated;
To ensure Stability test/study conducted as per plan
To approve specifications, sampling instructions, test methods and other Quality Control operational procedures as the function head;
To approve and monitor any contract test as the delegate of Head of quality;
To ensure the qualification and maintenance of his department, premises and equipment;
To ensure that the appropriate validations are done;
To ensure that the required initial and continuing training of the department personnel is carried out and adapted according to need.
Establish key performance indicator (KPI) for quality control department and provide trend of quality performance periodically
Provide leadership, guidance and development opportunities for direct reports
Other duties as assigned by superior
职位要求:
Minimum of 7 years of experience in QC Lab in pharmaceutical industry, and at least more than 5 years analytical background
Capability of controlling and completing multiple issues with a clear sense of priority
Demonstrated experience in leading and driving high performing teams
Ability to analyze and resolve issues
English: fluent in writing and Speaking
Commitment to Quality and Compliance, operate at the highest global standards, hominization with Global quality standard to achieve continual improvement
Responsible for technical assessment for a contract lab to support GMP operation, support the Contract lab oversight.
To approve COA/ADS, as the sees fit, starting materials, packaging materials, intermediate, bulk and finished products as the delegate of Head of Quality;
To ensure that all necessary testing is carried out and the associated records evaluated;
To ensure Stability test/study conducted as per plan
To approve specifications, sampling instructions, test methods and other Quality Control operational procedures as the function head;
To approve and monitor any contract test as the delegate of Head of quality;
To ensure the qualification and maintenance of his department, premises and equipment;
To ensure that the appropriate validations are done;
To ensure that the required initial and continuing training of the department personnel is carried out and adapted according to need.
Establish key performance indicator (KPI) for quality control department and provide trend of quality performance periodically
Provide leadership, guidance and development opportunities for direct reports
Other duties as assigned by superior
职位要求:
Minimum of 7 years of experience in QC Lab in pharmaceutical industry, and at least more than 5 years analytical background
Capability of controlling and completing multiple issues with a clear sense of priority
Demonstrated experience in leading and driving high performing teams
Ability to analyze and resolve issues
English: fluent in writing and Speaking
职能类别:生物工程/生物制药
公司介绍
百济神州是一家立足于科学的全球性生物科技公司,专注于开发创新、可负担的药物,旨在为全球患者改善治疗效果,提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作,加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。
联系方式
- Email:shan.liu@beigene.com
- 公司地址:昌平区生命科学园 (邮编:102206)