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Sinead Cullen
Life Science

01 507 9252
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Details

Clinical Trial Quality Representative


Reference:SCA014354 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Research Associate, Clinical Research Nurse, Clinical Trials Assistant, QA Analyst, QA Executive, QA Specialist, Quality Assurance Officer, Quality Systems Lead

Clinical Trial Quality Representative
Our client, a global pharma organisation are currently recruiting for a Clinical Trial Quality Representative to join their Medicines Quality Organisation (MQO) team on a permanent basis. For this role, you will have experience working with Clinical Trials and Quality Management Systems. This a Senior Associate/Principal Associate level role and offers hybrid working. A more detailed role profile is available upon request.

Responsibilities

  • Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents. Ensures the regional and/or affiliate quality system requirements have clear accountabilities
  • Recommends new quality system documents or changes to existing quality system documents where applicable
  • Advise on appropriate training for implementation and documentation
  • Provide consultation on the interpretation and practical application of external requirements, standards, and procedures
  • Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
  • Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary
  • Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps
  • Complete self-inspections and drive improvements that are meaningful and actionable
  • Ensure local implementation of the quality systems as necessary
  • Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned
Requirements
  • Bachelor’s Degree in a science/technology/health care related field or equivalent work experience
  • Demonstrated ability to apply quality systems within a regulated work environment
  • Experience in a quality control/quality assurance role
  • Experience in defined functional business areas, for example, medical writing, regulatory affairs, or clinical trial management.
  • Effective project and time management skills
  • Demonstrated ability to communicate effectively, both written and verbal, and to influence others
  • Demonstrated ability to prioritize and handle multiple concurrent tasks
  • Strong interpersonal skills with demonstrated flexibility in varying environments/geographies
  • Effective organization/self-management skills
  • Ability to work independently and as part of a team
For more information please contact Sinéad Cullen on +353879500821 or [email protected]