北京招聘

职位描述：
Key duties/responsibilities:
? Implementation of the quality system including
o implementation of quality standards
o training management and registration (learner curricula, learning plans and manual entry of training information)
o documentation management to ensure a good traceability of the activities: processing requests for new documents, managing change requests, coordinating document validity reviews, issue controlled documentation for laboratory worksheets
? Review of laboratory records and testing data to assess compliance with protocol requirements, laboratory procedures and applicable industry/regulatory practices
? Review and approbation of the deviation, investigation and CAPA
? Management of the reception and storage of the cell banks, review of the controls to prevent any contamination risk (mycoplasma, virus, bacteria)
? Check of the equipment and facilities management including the warehouse
? Provide quality support on selected, large-scope projects as needed
? Develop expertise in drug cGMP regulations and ISO 9001 standards to provide guidance, training and compliance assessments as needed
Required Experience, Skills and Training
? Minimum 5 years in a quality assurance or quality control role, Pharmaceutical companies background preferred
? Minimum 5 years in a cGMP or ISO environment
? Proficient with Microsoft Word, Excel, Project
? Excellent written and verbal communication skills
? Certified Quality Auditor or equivalent preferred
? Experience with cGMP calibration and validation protocol and report review/approval
? Familiar with CFDA regulations



Preferred Experience, Skills and Training
? Working knowledge of laboratory information databases such as Trackwise preferred
? Can communicate effective verbally in English
? Thorough understanding and practical application experience of Quality Risk Management
? Lean & Six Sigma or Operational Excellence training/certification
? Thorough understanding and practical application of 21CFR Parts 11, 210, 211 and 820

Education
? Master degree in a life science 举报 分享

Merck – Living Innovation
默克 – 创新引领生活

默克是一家全球领先的医药与化工公司，以创新和高科技优质产品闻名世界。

默克在全球66个国家与地区拥有约38,000名员工，致力于改善患者的生活质量，助力客户实现长远的成功和迎接全球化挑战。

默克旗下四大业务分支——默克雪兰诺、消费者健康、功能性材料和默克密理博——2012年总收入达112亿欧元。

默克是全球历史最悠久的医药与化工公司。自1668年起，默克就成为了创新、成功和负责任的企业家精神的代名词。默克家族作为公司的创始人至今仍持有默克大部分的股份。

我们是默克，正根正源，在全球拥有“默克”这一名称和品牌的所有权。唯一的例外是在美国和加拿大，我们使用“EMD”的名称。
Merck – Living Innovation

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors.
Around 38,000 employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges.
We generated total revenues of