WuXi AppTec

  • QA Project Lead/ Product Release

    Job Locations CN-Shanghai
    Job ID
    2018-4116
  • Responsibilities

    •  Be responsible for tracing all quality questions in the GMP manufacturing process.
    • Be responsible for maintaining the relationship both the client and company and communicating with the client smoothly.
    • Attend the daily quality meeting with the client and raise/ solve the relevant quality questions.
    • Be responsible for answering the questions between client QA and internal QA.
    • Be responsible for tracing the relevant deviation, CAPA and change control for the project.
    • Attend the audit work for project.
    • Attend the daily CMC meeting on time.
    • Be responsible for reviewing the executive MBR, collecting the relevant documents to complete the batch releasing.
    • Assistant to optimize the releasing process and update the relevant SOPs.
    • Organize the release meeting periodically and trace the progress.
    • Be responsible for the release testing
    • Complete the temporary work by the director.

    Qualifications

    • College degree or above with a major in chemistry, biology, biochemistry, chemical engineering, bioengineering, or related field.
    • More than 6 years working the relevant biological pharmacy industry and be familiar with the progress.
    • More than 4 years direct working experience in QA in pharmaceuticals/biotech/medical device manufacturing or related fields.
    • Good communication and coordination skills.
    • Good written and verbal communication skills in English and Chinese.
    • More than 4 years for quality management experience.
    • Manage the team with more than 2 years experiences.

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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