QC Operation Management Specialist - Tuas - WuXi AppTec

    WuXi AppTec
    WuXi AppTec Tuas

    9 hours ago

    Pharmaceutical / Bio-tech
    Description

    Responsibilities:

    • Responsible for the management of samples, reference standards, column and reagents.
    • Perform Lab procedures for the management of samples, reference standards column and reagents.
    • Timely report lab issues of any sample or reference standard and ensure GMP compliance.
    • Involve the update the lab operation procedure, ensure execution.
    • Use instruments as per Lab procedure, maintain Lab equipment as in good order, conduct preliminary trouble shooting, timely report instrument issues.
    • Timely document the observations in case of Lab event, OOX and deviations and involve in the investigations if necessary.
    • Proactively study regulatory documents from various countries, such as BP, USP, JP, and EP, and refer to these documents when updating internal procedures.
    • Participate in customer audits and government inspections, promptly address identified issues, and ensure GMP compliance.
    • Keep track of the progress of work in a timely manner, enhance communication with other internal departments, and establish stable and good relationships.
    • Responsible for other tasks temporarily assigned.
    • Assist department leaders in building a high-efficiency team.

    Requirement:

    • Pharmacy or Chemistry related major
    • Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations.
    • Proficient in English or Mandarin, proficient in both Mandarin and English are preferred, to communicate with team from China and overseas for technical transfer.
    • Good computer skills.
    • At least one year experience of GMP Lab related work.
    • Familiar with the management of analytical laboratories within the industry;
    • Strong ability to handle on-site issues, with good coordination, communication, and execution skills;
    • Detail-oriented, proactive, and able to work under pressure
    • Ability to determine problems, gather information, understand facts, and draw correct and effective conclusions through scientific reasoning.

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