Signant Health

  • QMS Specialist

    Job Locations UK-UK Remote
    Job ID
    2019-4152
    Category
    Quality Assurance
    Position Type
    Fixed Term Contractor - Full-Time (EU)
  • Role Overview

    3 month contract that could potentially transition into a permanent position.

     

    The Quality Management Systems Specialist ensures thorough reviews of Signant Heath’s QMS Documents. The individual with provide a Gap analysis to determine the actions needed to achieve the regulatory compliant QMS. Raising basic awareness of risk management concepts and mechanisms so that employees can effectively identify and manage risks within their own functional area. Provide an independent evaluation of the existing QMS to assess compliance with current regulations and guidance. Assist in restructuring and updating the QMS to simplify it and improve compliance as a result of consolidation of the QMS from two companies following merger.

    Key Accountabilities/Decision Making & Influence

    • The review of company QMS Documents
    • Ensuring QA compliance with regards to ICH/FDA, GCP, SOPs, EU directives and national/local guidelines
    • Collaboratively work with stakeholders to develop project charter and define roles and responsibilities
    • Interview key stakeholders to access the current state and define the desired state
    • Review relevant SOPs or Policies and associated tools and Working Instructions.
    • Identify gaps related to external regulations and leading practice
    • Provide a gap assessment report and implementation roadmap to close gaps
    • Provide a redundancy assessment report and implementation roadmap to remove redundancies
    • Providing GCP/QA consultation for company staff in creation and revision of QMS documents
    • Applies risk-based principles for computer systems compliance issues in alignment with Signant Health policies and standards
    • Provides support for other compliance related initiatives
    • Coordinate project planning, execution, monitoring and reporting
    • Other project work and responsibilities as required

    Knowledge, Skills & Attributes

    • Bachelor’s degree or commensurate experience

     

    • At least a year of work experience involving supporting multiple projects/processes in a fast-paced work environment.
    • Understanding of QMS process in a regulatory environment
    • High degree of self-motivation and attention to detail.
    • Superior English language verbal/written communication and interpersonal skills including the ability to deliver information effectively and facilitate team processes in person and via telephone or e-mail.
    • Ability to work collaboratively and take direction from multiple inputs.
    • Ability to manage and meet multiple deadlines and respond to multiple requests for support.
    • Proficient computer skills including Word, Excel, Outlook and PowerPoint. Familiarity with Visio preferred.
    • Ability to quickly learn and apply new skills, procedures and approaches.
    • Demonstrated ability to meet very short deadlines & multi-task in an extremely fast-paced work environment with little direct supervision.
    • Proven ability to work in a team-oriented environment, providing back-up support to team members & establishing/maintaining effective work relationships with co-workers within and across functional areas.
    • Previously demonstrated proactive and positive approach to tasks and projects overall, as well as to the types of scheduling & process changes that are inherent in a fast-paced business.

     

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