Laboratory Quality Coordinator - ISO 15189

vendredi 19 mai 2017
Date limite
lundi 19 juin 2017
Andrea Baetens
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Laboratory Quality Coordinator - ISO 15189 Organisation description:

For our client, a leader in the pharmaceutical sector, we are looking for a QA Consultant for the certification ISO 15189 of a new lab.

Interested in working as a consultant that would support the implementation an analytical laboratory In-house for processing safety Laboratory test and will be responsible for the implementation of the ISO 17025?

Job description:

As the lab coordinator you will actively participate in the implementation of the accreditation ISO 17025 in the laboratory of our client. 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.

But what else is required of you?

  • You implement and validate new assays in clinical chemistry, hematological, coagulation, and urinalysis on appropriate automate to support PCRU BR needs.
  • You develop and maintain quality processes and SOPs in the Safety laboratory.
  • You direct collaboration with the Laboratory team to execute and coordinate the qualitative actions within the framework ISO 17025.
  • You participate in the implementation of the Laboratory Information Management System from a point of view scientific.
  • You monitor of quality indicators, treatment of Non-conformities and claims as well as Corrective and preventive actions.
  • You perform all quality control checks monitoring trends (Participation in the Quality Management System of the Laboratory).
  • You ensure the control of the Safety laboratory environment, safety specification, maintenance and calibration of laboratory material required to conduct clinical activities.
  • You ensure Safety Laboratory readiness for audits. Support and respond to internal and external Quality audits.
  • You assure compliance of processes for all activity in the Safety analytical laboratory Identify and implement new operational work process to improve Safety laboratory efficiency.
  • You prioritize and coordinate all efforts within the PCRU 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.
  • You represent the PCRU on global initiatives as a Laboratory subject matter expert, including regular interaction with the New Haven PCRU for best practices and complementarity.
  • You perform other related duties incidental to the work described herein.
  • You comply with our client Standards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation.

For this position we are looking for?

  • You have a Scientific Master Degree or equivalent by experience.
  • You have a good experience in quality and you have already worked on certification project.
  • You have good knowledge of Lab environment
  • Good knowledge and experience in ISO 15189 and/or ISO17025 is a must.
  • You have good communication skills and team spirit.
  • You are fluent in French and English.

Why work as a consultant at XPE Pharma & Science?

  • XPE is a part of the Adecco group, one of the top 5 companies for 'Best Place To Work'
  • You will work in a very dynamic environment with motivated colleagues
  • You will get the chance to improve and develop your skills and competences
  • Interesting salary (Mealvouchers, Eco vouchers, Group- and hospitality insurance, ...)

XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713