Senior Quality Specialist/高级质量专员 上海

月薪： 0.5-2.5万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 02-10 发布
  • 五险一金
  • 补充公积金
  • 员工旅游
  • 专业培训
  • 绩效奖金
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

Key Job Responsibilities:Project work in all project sizes and phases as per business needs.Solve tasks independently, to the highest degree of complexity.Structure and plan the work of own discipline in small projects. Ensure interfaces to and coordination with other disciplines. Ensure changes to the scope of work are brought to the attention of the project management. Ensure quality/review and compliance with codes and regulations of own and customers’ work.Introduces, interprets, reviews and ensures the full implementation of regulations and guidance documents from international and national regulatory authorities. Assesses compliance risk and recommends corrective action.Be able for readiness preparation for GMP, GSP, ISO9001 and other quality system inspections, and other quality system inspections by executing readiness plan.Plans and leads internal audit to identify gaps and provide recommendation for solutions. Establishes and manages quality management systems, e.g. Deviation, CAPA and Change Control process; Be able to monitor the progress to ensures the on time closure and submission of execution summary to operation committee.Be able to audit External suppliers, manufacturers and contractors.Draft and negotiate the Quality Agreement based on newest regulations if necessary.Monitor contractors, implement quality audit and follow up CAPA. Education and Languages:Bachelor in life sciences or related science/engineering background with a strong emphasis in biologics.Fluent in Chinese & English (written) is required. Professional Skills and Experiences:Minimum of 5 years of relevant quality experience in pharmaceutical companies or consultancy companies, preferred background of biopharmaceutical products. Knowledgeable of CFDA pharmaceutical regulations and regulatory landscape of other important country/regions (eg. China, Japan, South Korea, EU, US).Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, international industrial best practice and guidance, regulatory and compliance requirements, aseptic processing. Knowledge/experience for regulations regarding complex biologics (i.e., monoclonal antibodies and recombinant proteins, novel therapy) expressed in mammalian cell culture.Experience working in a global, matrix environment. Personal Skills and Competencies:Strong organizational and time management skills.Good project management skills. Ability to train and educate others.Effective management by influence.Ability to work in multi-cultural teams.Good listening skills with the ability to analyze and respond to given situations quickly and effectively.Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.Ability to indirectly influence other organizations and cultures.Proficient in MS Office Software (Word, Excel, PowerPoint, Project).Able and willing to travel frequently. 职能类别： 药品注册 合规主管/专员 关键字： 合规 药品法规

联系方式

浦东新区张江高科

公司信息

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

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