• Quality Management (QM) Administrator

    Job Locations RO-Iasi, Romania
    Job ID
    2017-2577
    Category
    Quality Assurance
    Position Type
    Permanent Employee - Full-Time
  • Position Summary

    Quality Management Administrator - Iasi, Romania

     

    Assist Quality Management and Regulatory Affairs in the implementation of the evolving and existing Quality Management Systems. Must collaborate with company staff to ensure that deliverables are being worked to deliver a quality product to CRF Health’s global pharmaceutical customers. Interfaces with customers on quality issues and audits under the direction of management.

    Responsibilities

    • Prepare for customer audits;
    • Train for customer audits;
    • Organize the outcome of the client audit reports and prepare for returns;
    • Review and assign all new NCR, track trend and inform teams of late NCRs;
    • Assist in preparing the quarterly KPI listing;
    • Liaison for all incoming emails or questions for the QM Team or Regulatory Team;
    • Print out documents needed during audit, training records, etc.;
    • New Hire Orientation trainer;
    • Update the Yearly refresher courses (3 of them);
    • Keep the Signature listings up to date in Intranet and QM CVS;
    • Send QM Monthly reminders to CRF Health Staff;
    • Assist with QM staff  travel arrangements if needed;
    • Track all QMS updates;
    • Schedule QM group training when needed;
    • Admin of the new QM document review management system, can allocate reviews and update/maintain the system;
    • Booking/arranging training slots for QM training;
    • Look after filing in CVS/QM drive;
    • Maintain QM intranet page;
    • Audit admin such as sending out vendor questionnaires, liaising with them for missing information/follow up questions, chasing outstanding audit responses, etc.;
    • Other duties as required.

    Requirements

    • Understanding of the pharmaceutical industry preferably with clinical trial or GxP experience;
    • Knowledge of ISO 9001 quality & principles;
    • Must have excellent writing, editing, time management, communications, presentation, and human relations skills;
    • Must be able to deal effectively with all levels of the organization;
    • Must be a team oriented person with a “can do” attitude.

     

    CRF Health aspires to be the market leading provider of patient centred eSource technology and service solutions focused on flexibility and innovation, underpinned by deep regulatory and technical knowledge and high-quality service delivery.

    We have operations in Finland, the US and the UK and continue to grow in terms of revenues, customer numbers and employees.

    CRF Health creates electronic Clinical Outcome Assessment (eCOA) solutions that are simple, scalable, and effective. From our collaborative, agile design approach to our user-friendly reporting tools, we streamline complex processes and deliver reliable results for superior clinical trial outcomes. We improve patient engagement with intuitive design, support study teams with tailored scientific insights, and secure high-quality data with precision. Above all, we ease the path to approval.

    Our personalized service and unparalleled eCOA expertise helps sponsors bring new medicine to market quickly and cost-effectively, improving lives across the world. More information on CRF Health to be found at www.crfhealth.com

    If this role isn't quite right for you then click here and search on all our current vacancies in Romania.

    The "Behaviours" we will measure you against - the "how you do it" - includes:

    • Embrace Collaboration
    • Own Your Contribution
    • Drive for Results and
    • Passion for the Customer

    How do the decisions in the design and analysis of mode equivalence studies affect study outcomes? Learn more

     

     

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