工作机会

    DB-Quality Assurance Auditor/ - Pudong, 中国 - WuXi AppTec

    WuXi AppTec
    WuXi AppTec Pudong, 中国

    1周前

    WuXi AppTec background
    描述

    职位描述:




    Primary Responsibilities and Accountabilities:

    • Independently perform Quality activities including preparation, conductance, presentation, and timely reporting of outcomes, and evaluation of actions executions.
    • Independently perform laboratory internal audits, facility inspections and study audits, recognize nonconformities, present observations and associated compliance risks to the teams, prepare audit reports.
    • Manage quality issues to ensure all actions are appropriately and timely addressed.
    • Lead discussions with team members and report any nonconformities and issues to management in a timely manner.
    • Review internal SOPs, review study plan, data, and report to identify issues.
    • Perform csv audit, provide compliance consultation related to csv related activities.
    • Identify and coordinate to resolve potential risk areas through working with the team and management
    • Provide training to business stakeholders as required.
    • Perform tasks as assigned by management.
    • Participate in authority inspections, CAP accreditations as needed.

    任职资格:




    Qualifications:

    • MS, BA degree in the quality related filed, or an equivalent education, training and experience.
    • Indepth knowledge, maintain awareness and expertise in GLP/GCLP/GCP regulations and standards.
    • 2 years' experience in pharmaceutical industry with Quality Assurance background in a CAP/ISO15189/CNAS/GLP laboratory is preferred.
    • Demonstrated knowledge in drug development and laboratory management.
    • Good management, high discipline and proactive.
    • Excellent communication skills and team work spirit.
    • Confluent in reading, writing and speaking English.
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