• Quality Management Specialist/Consultant - Interim Opportunity - 4 months initial duration

    Job Locations UK-Hammersmith, London, UK
    Job ID
    2018-2914
    Category
    Quality Assurance
    Position Type
    Contractor/Freelance
  • Position Summary

    Assist Quality Management stream in the development and implementation of the evolving and existing Quality Management Systems. Must collaborate throughout the product life cycle with software developers, usability experts, project managers, software testers and other professionals to engineer and deliver a quality product to CRF Health’s global pharmaceutical customers. Interface with customers on quality issues and audits under the direction of management.

     

    Must have proven GCP and CSV experience.

    Responsibilities

    • Provides quality input to projects and performs quality reviews of project deliverables to ensure that all products are released with levels of quality that meet and/or exceed customer
    • Manages the Non-Conformance / Corrective Action processes from inception, root cause analysis, and closure
    • Develops partnerships with other functional areas including Development, Client Services, Support Services and end users
    • Creates and nurtures a climate for technical and quality innovation
    • Helps to promote a vision for the Quality Management team that transcends traditional testing, applying state- of-the art concepts of product modeling, test automation and SQA to efficiently and effectively carry out tasks
    • Helps in the development, building and maintaining quality systems, reviewing and assisting in authoring SOP’s, developing and implementing training programs
    • Takes an active role in simplifying procedures while maintaining regulatory compliance
    • Directs/Hosts internal and external audits
    • 10% - 15% travel required
    • Other responsibilities will be assigned as required

    Requirements

    • Bachelors Degree, advanced degree desirable or equivalent experiences determined by the hiring manager
    • Minimum of five years experience in quality assurance/quality control activities surrounding the testing and/or validation of software products, or relevant experience
    • Understanding of the pharmaceutical industry preferably with clinical trial (GCP) or GxP experience
    • Knowledge of ISO software quality standards, principles and methodologies. ISO 9001, ISO 12207, ISO 27002
    • Must have excellent writing, editing, time management, communications, presentation, human relations, and project execution skills
    • Must have excellent configuration and document management skills
    • Must be able to portray a professional appearance and presentation to the customers
    • Must be able to deal effectively with all levels of the
    • Must be a team oriented person with a “can do” attitude

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