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quality coördinator lab

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Sophie Steels
Career Manager


Postulez ici

Sophie Steels
Career Manager



Sophie Steels
Career Manager


Description de l'emploi

  • Actively participates in the implementation of the accreditation ISO 17025 in the laboratory Participation in the project management and the follow -up with all external supplier. Example : implementation of the QMS (Quality management system) as required by ISO 17025.
  • Implement and validate new assays in clinical chemistry, hematological, coagulation, and urinalysis on appropriate automate to support our client needs. 
  • Develops and maintains quality processes and SOPs in the Safety laboratory.
  • Direct collaboration with the Laboratory team to execute and coordinate the qualitative actions within the framework ISO 17025. 
  • Participation in the implementation of the Laboratory Information Management System from a point of view scientific.
  • Monitoring of quality indicators, treatment of Non-conformities and claims as well as
  • Corrective and preventive actions.
  • Perform all quality control checks monitoring trends (Participation in the Quality Management System of the Laboratory).
  • Ensure the control of the Safety laboratory environment, safety specification, maintenance and calibration of laboratory material required to conduct clinical activities.
  • Ensure Safety Laboratory readiness for audits. Support and respond to internal and external Quality audits.
  • Assure compliance of processes for all activity in the Safety analytical laboratory Identify and implement new operational work process to improve Safety laboratory efficiency.
  • Prioritize and coordinate all efforts within the lab  and collaborate between disciplines/divisions (Clinical Development, Clinical Research Operations, Clinical Pharmacokinetics, Pharmacogenetics, and other Clinical Research Units) to resolve issues and accomplish organizational goals.
  • Represent the client on global initiatives as a Laboratory subject matter expert, including regular interaction with the client for best practices and complementarity.
  • Perform other related duties incidental to the work described herein.
  • Complying with theStandards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation.


Profil

  • Minimum of a Diploma bachelor degree in Medical Biology or equivalent.
  • 3 years experiences in ISO 17025 and/or 15189
  • Experience in Clinical Research or experience in analytical techniques and full knowledge of analytical validation procedure is required. 
  • Strong knowledge in ISO 17025 and/or 15189.
  • Significant track record of experience and accomplishment in clinical and/or research laboratory setting.
  • Thorough knowledge of clinical pharmacology and regulatory requirements.
  • Experience with managing projects.
  • Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines.
  • Candidate must possess strong problem solving abilities.
  • Demonstrated ability to function as an effective and professional team member in diverse workgroups to accomplish business objectives.
  • Good understanding of medical, clinical research, Lab Data Management process and terminology.
  • Excellent communication, planning and organization skills required.
  • IT Knowledge : Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.
  • Language skills : Good written and verbal skills in English, French and/or Dutch are essential
  • Excellent organizational and time-management skills.
  • Excellent communication skills), including public presentations and ability to communicate complex concepts clearly and concisely.
  • Developing processes for continual improvement.




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