高级质量助理-上海

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Date: 1 Nov 2024

Location: Shanghai, Shanghai, CN, 201203

Company: Merck KGaA Darmstadt, Germany

 

与我们携手施展你的超能力！  

 

探索未知、打破壁垒、勇于发现，你准备好了吗？你有宏图大志正待实现，我们同样雄心勃勃。我们遍布全球的员工热爱科技创新，以医药健康、生命科学和电子科技领域的解决方案，切实改善人类生活。我们怀揣远大梦想，热忱关爱员工、客户、患者和人类居住的这颗星球。因此我们一直在寻找永葆好奇心的你，与我们一路同行、敢想敢做，把不可能变为可能！ 

 

Your role:

 

Senior Quality Assistant is to promote and integrate quality into every aspect of our testing business in China. The role is to perform document control and document archival to support all aspects of quality operations to ensure that laboratory testing operates in full compliance with GxP and Standard Operating Procedures (SOPs).

 

The post holder will be able to perform the following functions independently, with minimal guidance.

 

Brief role description:

 

  • Document control: Manage electronic document management system for review and approval of GxP documents, including Protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs and all other QMS documentation.
  • Document control: Perform training for new hires with regards to the use of the electronic document management system
  • Document archival: Ensure compliance with GxP regulations and SOPs with regards to document archival. Perform document archival in a timely manner.
  • Document archival: Responsible for document archival on-site and coordination for off-site archival.
  • Comply with Health and Safety Executive regulations and undergo relevant training modules when required and actively takes necessary action when encountering unsafe situations.
  • Perform their duties according to the principles of Good Laboratory (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

 

The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post

 

Who you are:

 

Education:

  • College degree in life sciences or higher
  • High science orientation

 

Experience:

  • Minimum of 3 – 4 years of experience, within a similar Quality Assurance role i.e. document control.
  • Shows a desire and motivation to work in Quality and regulated environment.
  • Awareness of Biologics regulatory environment and GMP manufacturing topics.
  • A proactive approach to all aspects of Quality.

 

Knowledge & Skills:

  • Fluent in reading and writting English. Native Chinese speaker.
  • Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues routinely.
  • Strong analytical and problem solving abilities.
  • Organized and logical in defining workload and delivering projects.

 

Core Competencies:

    • Technical and problem solving skills
      • Has the functional and technical knowledge and skills to do the job
      • Can learn new skills and knowledge quickly
      • Uses logic to solve problems with effective solutions
      • Makes good decision
    • Energy and Drive
      • Self-motivating; is action-oriented and full of energy for the things he / she sees challenging
      • Pursues everything with energy, drive and the need to finish, especially in the face of resistance and setbacks
      • Can be counted on to achieve goals, constantly and consistently, pushes self and others for results
    • Professional and interpersonal skills
      • Relates well to all kinds of people in the organization, builds constructive and effective relationships using diplomacy and tact
      • Is seen as a team player, cooperative, easily gains support of peers, encourages collaboration

 

 

Additional Local Needs:

Global mindset and to be willing to engage in conference calls at out-of-office hours.


我们能够提供：我们对未知充满好奇，我们的员工有着多样化的背景、多维度的视角和个性化的经历。作为一家前沿科技企业，我们欣赏全方位的多元性，坚信这能驱动卓越和创新，从而强化我们“科技先锋”的底色。同时我们致力于为所有员工提供机会和资源，支持他们按各自的节奏充分成长和发展。加入我们，共建充满包容性和归属感的企业文化，让每一位志同道合的伙伴能够施展自己的超能力，共同推动人类迈向进步的未来!

 

立即申请，成为我们多元化团队的一员！
 


Job Segment: Document Control, QA, Quality Assurance, Document Management, Laboratory, Administrative, Technology, Quality, Science

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