Microbiologist

4 jours restants

Région
Wavre
Publication
jeudi 31 août 2017
Date limite
samedi 30 septembre 2017
Réf
78FE6XPE-BE
Contact
Julie Begine
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: Microbiologist Organisation description:

XPE Pharma & Science offers a unique combination of providing high qualified Scientific, Technical, Commercial and/or Medical expertise through staffing, consultancy, Project management or Project delivery services.

We have more than 250 XPErts helping out our clients in different phases of the development process of a drug/medical device or product.

As a full service organization XPE Pharma & Science offers those specialized HR & project services to Pharmaceutical, Biotech, Medical devices, Agri-food Industries and the Healthcare & CRO environment.

Expert in clinical microbiology diagnostic assays: contribute to the clinical read-out strategy by managing the technical and scientific oversight of clinical microbiology activities in multi-countries local laboratories to support one or several vaccine development programs. Manage scientific assessment and oversight of lab activities in agreement to GxP requirements (GMP, GCP, GCLP).

Job description:

Responsible for the scientific and technical oversight of clinical microbiology testing in multi-countries local laboratories supporting one or several projects:

  • In charge of supporting Local Operating Companies (LOC) for the initial feasibility steps of the local lab proposal, including direct interaction with the local labs
  • Ensure fit for purpose of the methods that will be used in the epidemiological/clinical studies and develop the Analytical plan accordingly
  • Perform (or support Clinical Research Associates) the local lab quality oversight (quality of operations but not the task coordination) and will be informed/consulted about deviations at local lab potentially impacting studies
  • Ensure alignment between the analytical plan and the activities performed, including data reporting
  • Document the microbiology certification of the local labs in CLS files until study end (incl. CLIA)

Manage communication related to scientific and technical oversight with health care professionals, external partners, local representatives and Clinical Laboratory Sciences (CLS) stakeholders to follow-up on study and local lab set-up, testing progress, assay or process deviations.

Review assay, equipment or process deviations, define & manage CAPAs. Escalate any risks and issues identified.

Share know-how in his/her field of competency and support others in their scientific/technical development. Present data in meetings within CLS or in front of external audience.

Provide support for the development and/or review of internal and external publications, documents (e.g. INDs, regulatory submissions and respond to questions from regulatory authorities during submission) and communications.

Participate to the follow up of collaborations with other teams/experts to share/gain scientific and technical expertise and for technology transfer within (i.e. Preclinical, QC) and outside. Participate to CLS and R&D knowledge management in the field of expertise.

Ensure all activities under responsibility are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations and internal policies. Apply good documentation practices (GDP) and manage human biological specimens and raw data in agreement to rules.

Offer:

What do we offer? Well for this position you will start as a Consultant at XPE Pharma & Science. As a consultant you will get an interesting salary package (contract of unlimited term) and extra-legal advantages!

If you are still interested, don't hesitate to apply…We have 2 working days to present your application with our client.

XPE is a part of the Adecco group, one of the top 5 companies for 'Best Place To Work'.



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