Laboratory Quality Coordinator - ISO 15189

Région
Anderlecht
Publication
vendredi 19 mai 2017
Date limite
lundi 19 juin 2017
Réf
74916XPE-BE
Contact
Andrea Baetens
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Fixe
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.
Profile:

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.
Offer:

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, ...)


Licenses
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